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ABSTRACT: Objective and background: For large epidemiological studies in low and middle-income countries, inexpensive and easily administered developmental assessment tools are called for. This report evaluates the feasibility of the assessment tool Ages and Stages Questionnaire 3.edition (ASQ-3) "home procedure" in a field trial in 422 North Indian young children. METHODS: ASQ-3 was translated and adjusted for a North Indian Hindi setting. Three examiners were trained by a clinical psychologist to perform the assessments. During the main study, ten % of the assessments were done by two examiners to estimate inter-observer agreement. During all sessions, the examiners recorded whether the scoring was based on observation of the skill during the session, or on caregiver's report of the child's skill. Intra class correlation coefficient was calculated to estimate the agreement between the raters and between the raters and a gold standard. Pearson product moment correlation coefficient and standardized alphas were calculated to measure internal consistency.Principal findings: Inter-observer agreement was strong both during training exercises and during the main study. In the Motor subscales and the Problem Solving subscale most items could be observed during the session. The standardized alphas for the total ASQ-3 scale across all ages were strong, while the alpha values for the different subscales and age levels varied. The correlations between the total score and the subscale scores were consistently strong, while the correlations between subscale scores were moderate.Conclusions/significance: We found that the translated and adjusted ASQ-3 "home procedure" was a feasible procedure for the collection of reliable data on the developmental status in infants and young children. Examiners were effectively trained over a short period of time, and the total ASQ scores showed adequate variability. However, further adjustments are needed to obtain satisfying alpha values in all subscales, and to ensure variability in all items when transferred to a North Indian cultural context.
Nutrition Journal 04/2013; 12(1):50. · 2.48 Impact Factor
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ABSTRACT: BACKGROUND: Micronutrient deficiencies can affect cognitive function. Many young children in low- and middle-income countries have inadequate cobalamin (vitamin B-12) status. OBJECTIVE: The objective was to measure the association of plasma concentrations of folate, cobalamin, total homocysteine, and methylmalonic acid with cognitive performance at 2 occasions, 4 mo apart, in North Indian children aged 12-18 mo. DESIGN: Bayley Scales of Infant Development II were used to assess cognition. In multiple regression models adjusted for several potential confounders, we measured the association between biomarkers for folate and cobalamin status and psychomotor or mental development scores on the day of blood sampling and 4 mo thereafter. RESULTS: Each 2-fold increment in plasma cobalamin concentration was associated with a significant increment in the mental development index score of 1.3 (95% CI: 0.2, 2.4; P = 0.021). Furthermore, each 2-fold increment in homocysteine or methylmalonic acid concentration was associated with a decrement in mental development index score of 2.0 (95% CI: 0.5, 3.4; P = 0.007) or 1.1 (95% CI: 0.3, 1.8; P = 0.004) points, respectively. Plasma folate concentration was significantly and independently associated with mental development index scores only when children with poor cobalamin status were excluded, ie, in those who had cobalamin concentrations below the 25th percentile. None of these markers was associated with psychomotor scores in the multiple regression models. CONCLUSIONS: Cobalamin and folate status showed a statistically significant association with cognitive performance. Given the high prevalence of deficiencies in these nutrients, folate and cobalamin supplementation trials are required to measure any beneficial effect on cognition. The study was registered at www.clinicaltrials.gov under the identifier number NCT00272116.
American Journal of Clinical Nutrition 01/2013; · 6.67 Impact Factor
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Rajiv Bahl,
Nita Bhandari,
Brinda Dube,
Karen Edmond,
Wafaie Fawzi,
Olivier Fontaine,
Jasmine Kaur,
Betty R Kirkwood,
Jose Martines,
Honorati Masanja,
Sarmila Mazumder,
Salum Msham,
Sam Newton,
Maureen Oleary,
Julia Ruben,
Caitlin Shannon,
Emily Smith, Sunita Taneja,
Sachiyo Yoshida
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ABSTRACT: Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.
The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrollment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.
The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.
Trials 02/2012; 13:22. · 2.02 Impact Factor
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ABSTRACT: To evaluate the Indian Integrated Management of Neonatal and Childhood Illness (IMNCI) programme, which integrates improved treatment of illness for children with home visits for newborn care, to inform its scale-up.
Cluster randomised trial.
18 clusters (population 1.1 million) in Haryana, India.
29,667 births in intervention clusters and 30,813 in control clusters.
Community health workers were trained to conduct postnatal home visits and women's group meetings; physicians, nurses, and community health workers were trained to treat or refer sick newborns and children; supply of drugs and supervision were strengthened.
Neonatal and infant mortality; newborn care practices.
The infant mortality rate (adjusted hazard ratio 0.85, 95% confidence interval 0.77 to 0.94) and the neonatal mortality rate beyond the first 24 hours (adjusted hazard ratio 0.86, 0.79 to 0.95) were significantly lower in the intervention clusters than in control clusters. The adjusted hazard ratio for neonatal mortality rate was 0.91 (0.80 to 1.03). A significant interaction was found between the place of birth and the effect of the intervention for all mortality outcomes except post-neonatal mortality rate. The neonatal mortality rate was significantly lower in the intervention clusters in the subgroup born at home (adjusted hazard ratio 0.80, 0.68 to 0.93) but not in the subgroup born in a health facility (1.06, 0.91 to 1.23) (P value for interaction = 0.001). Optimal newborn care practices were significantly more common in the intervention clusters.
Implementation of the IMNCI resulted in substantial improvement in infant survival and in neonatal survival in those born at home. The IMNCI should be a part of India's strategy to achieve the millennium development goal on child survival.
Clinical trials NCT00474981; ICMR Clinical Trial Registry CTRI/2009/091/000715.
BMJ (Clinical research ed.). 01/2012; 344:e1634.
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ABSTRACT: Poor micronutrient status is associated with diarrheal illness, but it is not known whether low folate and/or cobalamin status are independent risk factors for diarrhea. We measured the association between plasma folate and cobalamin and subsequent diarrheal morbidity in a prospective cohort study of 2296 children aged 6-30 mo in New Delhi, India. Plasma concentrations of folate, cobalamin, total homocysteine (tHcy), and methylmalonic acid were determined at baseline. Whether a child had diarrhea was recorded during weekly visits in a 4-mo zinc supplementation trial. Diarrhea episodes lasting <7, ≥7, and ≥14 d were classified as acute, prolonged, and persistent, respectively. There was a total of 4596 child periods with acute, 633 with prolonged, and 117 with persistent diarrhea during follow-up. Children with plasma folate concentrations in the lowest quartile had higher odds of persistent diarrhea than children in the other quartiles [adjusted OR = 1.77 (95% CI = 1.14, 2.75); P = 0.01]. This effect differed between boys [adjusted OR = 2.51 (95% CI = 1.47, 4.28)] and girls [adjusted OR = 1.03 (95% CI = 0.53, 2.01); P-interaction = 0.030]. We found a small but significant association between high plasma tHcy concentration and acute diarrhea [adjusted OR = 1.14 (95% CI = 1.04, 1.24); P = 0.006]. Plasma cobalamin concentration was not a predictor of diarrheal morbidity. In conclusion, poor folate status was an independent predictor of persistent diarrhea in this population.
Journal of Nutrition 12/2011; 141(12):2226-32. · 3.92 Impact Factor
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ABSTRACT: The observed effect of zinc supplementation on diarrheal morbidity varies between trials and there is a need to identify subgroups most likely to benefit from improved zinc nutriture. In a randomized, double-blind trial in 2296 children in New Delhi, India, we assessed whether baseline cobalamin or folate status modified the effect of zinc supplementation on the incidence of prolonged (≥ 7 d duration) and acute diarrhea. Children aged 6-30 mo received zinc or placebo daily for 4 mo. We measured plasma concentrations of folate, cobalamin, total homocysteine (tHcy), and methylmalonic acid (MMA) at enrollment and assessed the efficacy of zinc supplementation in subgroups based on these variables. The efficacy of zinc on reducing the risk of prolonged diarrhea was higher in those with plasma cobalamin concentrations below the 25th percentile and in those with tHcy and MMA concentrations above the 75th percentile. The OR (95% CI) for children below and above the 25th percentile for cobalamin were 0.53 (0.35-0.78) and 0.90 (0.73-1.11), respectively (P-interaction = 0.015). There were similar differences for the OR when comparing efficacy in those above and below the 75th percentile for tHcy and MMA (P-interaction = 0.045 and 0.188, respectively). Baseline folate status did not modify the effect of zinc on prolonged diarrhea. Neither cobalamin nor folate status influenced the effect of zinc on acute diarrhea. Children with poor cobalamin status benefited more from zinc supplementation for the prevention of prolonged diarrhea.
Journal of Nutrition 06/2011; 141(6):1108-13. · 3.92 Impact Factor
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ABSTRACT: To determine if educating caregivers in providing zinc supplements to infants < 6 months old with acute diarrhoea is effective in treating diarrhoea and preventing acute lower respiratory infections (ALRIs), and whether it leads to a decrease in the use of oral rehydration salts (ORS).
In this retrospective subgroup analysis of infants aged < 6 months, six clusters were randomly assigned to intervention or control sites. Care providers were trained to give zinc and ORS to children with acute diarrhoea at intervention sites, and only ORS at control sites. Surveys were conducted at 3 and 6 months to assess outcomes. Differences between intervention and control sites in episodes of diarrhoea and ALRI in the preceding 24 hours or 14 days and of hospitalizations in the preceding 3 months were analysed by logistic regression.
Compared with control sites, intervention sites had lower rates of acute diarrhoea in the preceding 14 days at 3 months (odds ratio, OR: 0.60; 95% confidence interval, CI: 0.43-0.84) and 6 months (OR: 0.72; 95% CI: 0.54-0.94); lower rates of acute diarrhoea in the preceding 24 hours at 3 months (0.66; 95% CI: 0.50-0.87) and of ALRI in the preceding 24 hours at 6 months (OR: 0.59; 95% CI: 0.37-0.93); and lower rates of hospitalization at 6 months for all causes (OR: 0.40; 95% CI: 0.34-0.49), diarrhoea (OR: 0.34; 0.18-0.63) and pasli chalna or pneumonia (OR: 0.36; 95% CI: 0.24-0.55).
Educating caregivers in zinc supplementation and providing zinc to infants < 6 months old can reduce diarrhoea and ALRI. More studies are needed to confirm these findings as these data are from a subgroup analysis.
Bulletin of the World Health Organisation 10/2010; 88(10):754-60. · 4.64 Impact Factor
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ABSTRACT: Our objective in this trial was to assess the impact of daily zinc supplementation on growth in young children. A double-blind, randomized, placebo-controlled trial was conducted in New Delhi, India. We enrolled 2482 children aged 6-30 mo who were supplemented daily with placebo or zinc (10 mg elemental zinc to infants and 20 mg to older children) for 4 mo. At enrollment, all children also received a single dose of vitamin A (104.7 micromol for infants and 209.4 micromol for older children). Weight and length were measured at enrollment and 4 mo later. Weekly visits were conducted by field workers to ascertain morbidity in the previous 7 d. Change in length, weight, length-for-age Z-scores (LAZ), and weight-for-length Z-scores (WLZ) after 4 mo of supplementation were assessed in the zinc and placebo groups. After 4 mo of supplementation, the weight and length gains in the 2 groups did not differ and there was no impact on LAZ, weight-for-age, and WLZ in the 2 groups. There was no substantial effect in any of the subgroups defined for age, income, gender, zinc levels in the crude analysis nor after adjusting for age, gender, income, breast-feeding status, and baseline anthropometric status. Despite successful zinc supplementation reflected in increased plasma zinc concentration and a substantially reduced incidence of diarrhea and pneumonia in zinc-supplemented children, the intervention did not have a beneficial effect on growth.
Journal of Nutrition 03/2010; 140(3):630-4. · 3.92 Impact Factor
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Rajiv Bahl,
Manju Saxena,
Nita Bhandari, Sunita Taneja,
Meera Mathur,
Umesh D Parashar,
Jon Gentsch,
Wun-Ju Shieh,
Sherif R Zaki,
Roger Glass,
Maharaj K Bhan
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ABSTRACT: A rotavirus vaccine previously licensed in the United States was withdrawn because it caused intussusception. Data on background intussusception rates in developing countries are required to plan pre- and postlicensure safety studies for new rotavirus vaccines. Also, it is unclear whether natural rotavirus infection is associated with intussusception.
Passive surveillance for intussusception in a large, well-defined, poor, urban population in Delhi, India, was conducted in 2 phases. Intussusception was confirmed by ultrasonography or surgery. Fecal samples obtained from patients with intussusception at study hospitals (irrespective of their residence in study areas) and healthy control subjects were tested for rotavirus with use of enzyme immunoassay. If available, resected intestinal tissue samples were tested for rotavirus with use of immunohistochemistical analysis and reverse-transcription polymerase chain reaction.
The incidence of intussusception requiring hospitalization was 17.7 cases per 100,000 infant-years of follow-up (95% confidence interval, 5.9-41.4 cases per 100,000 infant-years). Detection rates of rotavirus in stool samples did not differ significantly between case patients and control subjects (4 of 42 case patients vs 6 of 92 control subjects), and no evidence of rotavirus was detected in any of the 22 patients with intussusception for whom intestinal tissue samples were available.
The incidence of intussusception among Indian infants appears to be lower than that reported in other middle- and high-income countries. Natural rotavirus infection does not appear to be a major cause of intussusception in Indian infants.
The Journal of Infectious Diseases 11/2009; 200 Suppl 1:S277-81. · 6.41 Impact Factor
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ABSTRACT: Rotavirus infections cause approximately 122,000 deaths among Indian children annually.
The neonatal rotavirus candidate vaccine 116E was tested in a double-blind, placebo-controlled dose-escalation trial in India. Two doses of the Vero cell-adapted vaccine were evaluated. One hundred eighty-seven infants received a vaccine dose of 1 X 10(4) focus-forming units (ffu) and 182 received a dose of 1 X 10(5) ffu in a 1:1 randomization with placebo recipients. Infants received the vaccine at 8, 12, and 16 weeks, separately from routine vaccines.
No significant differences in clinical adverse events or laboratory toxicity were observed between vaccine and placebo recipients. There were no vaccine-related serious adverse events. A 4-fold increase in rotavirus immunoglobulin A titer was observed in 66.7% and 64.5% of infants after the first administration and in 62.1% and 89.7% of infants after 3 administrations of doses of 1 X 10(4) ffu and 1 X 10(5) ffu, respectively; the differences between these groups and placebo recipients were statistically significant.
Three administrations of vaccine doses of 1 X 10(4) ffu and 1 X 10(5) ffu were safe. The 1 X 10(5)-ffu dose of 116E demonstrated a robust immune response after 3 administrations. These favorable results warrant further development of the vaccine candidate and provide optimism that vaccinating infants in the developing world will prevent serious sequelae of rotavirus infection. Clinical trials registration. NCT00439660 and ISRCTN57452882 .
The Journal of Infectious Diseases 07/2009; 200(3):421-9. · 6.41 Impact Factor
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ABSTRACT: Low-birth-weight infants may have impaired zinc status, but little is known about the effect of zinc supplementation.
The objective was to investigate the effect of daily zinc supplementation on morbidity and anthropometric status in hospital-born, low-birth-weight infants.
In a double-blind, randomized, placebo-controlled trial, 2052 hospital-born term infants with a birth weight < or =2500 g were randomly assigned to receive zinc or placebo. The zinc group received elemental zinc: 5 mg/d for those infants between ages 2 wk and 6 mo and 10 mg/d for those infants aged >6 mo. All-cause hospitalizations, prevalence of diarrhea, acute lower respiratory tract infections, visits to health care providers, weights, and lengths were ascertained at 3, 6, 9, and 12 mo of age.
The supplement was consumed for >85% of the follow-up period. Mean plasma zinc at 12 mo of age was higher in the zinc group (100.2 microg/dL) than in the control group (73.3 microg/dL) (difference in means: 26.9; 95% CI: 19.6, 34.2). The 24-h and 7-d prevalence of diarrhea and acute lower respiratory tract infections was similar at 3, 6, 9, and 12 mo. Care-seeking for illness was significantly lower in the zinc group (difference in proportions: -5.7; 95% CI: -9.9, -1.4; P < 0.05) at 9 mo. The numbers of hospitalizations, weights, and lengths were all similar at all 4 assessments.
Hospital-born, term, low-birth-weight infants do not seem to benefit substantially from zinc supplementation that meets the Recommended Dietary Allowance for zinc in terms of morbidity or physical growth during infancy in this setting. This trial was registered at www.clinicaltrials.gov as NCT00272142.
American Journal of Clinical Nutrition 06/2009; 90(2):385-91. · 6.67 Impact Factor
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ABSTRACT: To compare the acceptability and energy intake of Ready-to-Use Therapeutic Food (RUTF) with cereal legume based khichri among malnourished children.
An acceptability trial with cross-over design.
Urban low to middle socioeconomic neighbor-hoods in Delhi.
31 children aged > or =6 to < or =36 months with malnutrition, defined as Weight for height (WHZ) < -2 to > or = -3 SD, with no clinical signs of infection or edema.
Children were offered weighed amounts of RUTF and khichri in unlimited amounts for 2 days, one meal of each on both days. Water was fed on demand. Caregivers interviews and observations were conducted on the second day.
Acceptability of RUTF compared to khichri based on direct observation and energy intake for test and control meals.
The proportion of children who accepted RUTF eagerly was 58% as against 77% for khichri. 42% children on RUTF and 23% on khichri accepted the meal but not eagerly. The median (IQR) energy intake over the two day period in children aged 6 to 36 months from RUTF was 305 (153, 534) kcal, and from khichri was 242 (150, 320) kcal (P=0.02). Conclusion: RUTF and khichri were both well accepted by study children. The energy intake from RUTF was higher due to its extra energy density.
Indian pediatrics 02/2009; 46(5):383-8. · 1.05 Impact Factor
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ABSTRACT: The purpose of this work was to evaluate whether education about zinc supplements and provision of zinc supplements to caregivers is effective in the treatment of acute diarrhea and whether this strategy adversely affects the use of oral rehydration salts.
Six clusters of 30,000 people each in Haryana, India, were randomly assigned to intervention and control sites. Government and private providers and village health workers were trained to prescribe zinc and oral rehydration salts for use in diarrheal episodes in 1-month-old to 5-year-old children in intervention communities; in the control sites, oral rehydration salts alone was promoted. In 2 cross-sectional surveys commencing 3 months (survey 2) and 6 months (survey 3) after the start of the intervention, care-seeking behavior, drug therapy, and oral rehydration salts use during diarrhea, diarrheal and respiratory morbidity, and hospitalization rates were measured.
In the 2 surveys, zinc was used in 36.5% (n = 1571) and 59.8% (n = 1649) and oral rehydration salts in 34.8% (n = 1571) and 59.2% (n = 1649) of diarrheal episodes occurring in the 4 weeks preceding interviews in the intervention areas. In control areas, oral rehydration salts were used in 7.8% (n = 2209) and 9.8% (n = 2609) of episodes. In the intervention communities, care seeking for diarrhea reduced by 34% (survey 3), as did the prescription of drugs of unknown identity (survey 3) and antibiotics (survey 3) for diarrhea. The 24-hour prevalences of diarrhea and acute lower respiratory infections were lower in the intervention communities (survey 3). All-cause, diarrhea, and pneumonia hospitalizations in the preceding 3 months were reduced in the intervention compared with control areas (survey 3).
Diarrhea is more effectively treated when caregivers receive education on zinc supplementation and have ready access to supplies of oral rehydration salts and zinc, and this approach does not adversely affect the use of oral rehydration salts; in fact, it greatly increases use of the same.
PEDIATRICS 06/2008; 121(5):e1279-85. · 4.47 Impact Factor
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ABSTRACT: Population-based data on the prevalence of cobalamin and folate deficiency in India are lacking.
The objective was to measure the prevalence of cobalamin and folate deficiency among children aged 6-30 mo residing in a low-to-middle income community in North India.
Children aged 6-30 mo (n = 2482) were identified through a community survey in a low-to-middle socioeconomic area in New Delhi, India. Non-fasting venous blood samples were collected before enrollment in another trial.
The median (interquartile range; IQR) cobalamin concentration in 6-11-mo-old children was substantially lower in breastfed (183; 120-263 pmol/L) than in nonbreastfed (334; 235-463 pmol/L) children. Cobalamin concentrations decreased progressively with increasing age in the nonbreastfed children. Median (IQR) plasma folate concentrations in the 6-11-mo-old group were higher in breastfed (20.3; 11.7-34.4 nmol/L) than in nonbreastfed (5.3; 3.4-7.7 nmol/L) children (P < 0.001). Folate concentrations decreased with increasing age in the breastfed children. In the nonbreastfed children, folate concentrations increased with increasing age. Low concentrations of plasma cobalamin (<150 pmol/L) were detected in 36% of breastfed and 9% of nonbreastfed children (P < 0.001). The proportions of children with plasma folate concentrations <5 nmol/L in these 2 subgroups were 6% and 33%, respectively (P < 0.001).
In north Indian preschool children, cobalamin and folate concentrations were commonly low and were associated with elevated total homocysteine and methylmalonic acid concentrations. Because low cobalamin and folate concentrations have functional consequences, population-based measures for improving cobalamin and folate concentrations need to be seriously considered.
American Journal of Clinical Nutrition 11/2007; 86(5):1302-9. · 6.67 Impact Factor
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ABSTRACT: Vitamin deficiencies are often part of malnutrition, which predisposes to acute lower respiratory tract infections.
The objective was to measure the association between cobalamin and folate status and subsequent respiratory morbidity.
A prospective cohort study was conducted in 2482 children aged 6-30 mo nested in a zinc supplementation trial. We measured plasma concentrations of folate, cobalamin, methylmalonic acid, and total homocysteine (tHcy) and followed the children for 4 mo.
We observed 1176 episodes of acute lower respiratory tract infections. Children with folate concentrations in the lowest quartile (interquartile range: 6.4-20.0 nmol/L) had a 44% higher incidence [adjusted incidence rate ratio (IRR): 1.44; 95% CI: 1.23, 1.70] of acute lower respiratory tract infections than did children in the other 3 quartiles. For tHcy, the IRR was 1.24 (1.07, 1.40) in a comparison of those in the highest quartile with those in the other quartiles. Breastfeeding was associated with high folate concentrations and protection against subsequent respiratory tract infections. This protection was significantly and substantially reduced after adjustment for plasma folate concentrations at baseline. Compared with the children in the other 3 quartiles, the IRR for being in the lowest quartile of cobalamin was 1.13 (0.76, 1.03) and for being in the highest quartile of methylmalonic acid was 1.12 (0.96, 1.31).
Poor folate status appears to be an independent risk factor for lower respiratory tract infections in young children. This study also suggests that the protective effect of breastfeeding is partly mediated by folate provided through breast milk.
American Journal of Clinical Nutrition 08/2007; 86(1):139-44. · 6.67 Impact Factor
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ABSTRACT: Preventing illness and improving growth in the first 6 mo of life is critical to reducing infant mortality. Zinc given for 14 d at the start of diarrhea has been shown to decrease the incidence and prevalence of diarrhea and pneumonia and improve growth in the 2-3 mo after, but no trial has been done in infants <6 mo of age.
This study sought to assess the effect of 14 d of zinc supplementation on subsequent morbidity and growth among infants 1-5 mo of age living in Pakistan, India, and Ethiopia.
Infants with acute diarrhea were randomly assigned to receive zinc (10 mg/d; n = 538) or placebo (n = 536) for 2 wk. Weekly follow-up visits were conducted for 8 wk after the diarrhea episode. Incidence and prevalence of diarrhea and prevalence of respiratory infections including pneumonia were compared between the groups. Changes in weight, length, and corresponding z scores during the 8 wk of follow-up were also compared.
One thousand seventy-four infants were enrolled at the start of follow-up. The groups did not differ significantly in the proportion of infants with at least one episode of diarrhea or respiratory infections. Infants who received zinc had more days of diarrhea (rate ratio = 1.20) than did the infants who received placebo. The groups had similar prevalences of pneumonia and overall respiratory infections. No significant differences in the mean changes in weight-for-age, length-for-age, and weight-for-length z scores were observed between the groups overall or in stratified analyses.
Young infants do not appear to benefit from 2 wk of zinc, unlike what has been observed among older children.
American Journal of Clinical Nutrition 03/2007; 85(3):887-94. · 6.67 Impact Factor
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ABSTRACT: Studies have found a substantial reduction in diarrhea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation administered with iron plus folic acid (IFA) in young children on all-cause hospitalizations and mortality in comparison with IFA alone was evaluated. In a double blind cluster-randomized controlled trial, 94,359 subjects aged 1-23 mo were administered a daily dose of zinc plus IFA or IFA alone for a duration of 12 mo after enrollment. The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron, and 50 microg of folic acid. The control group tablets were similar except that they contained a placebo for zinc. Infants aged <6 mo were administered half a tablet, and those older received 1 tablet dissolved in breast milk or water. Hospitalizations were captured by trained study physicians through the surveillance of 8 hospitals. Deaths and hospitalizations were ascertained through visits to households by study supervisors once every 2 mo. The overall death rates did not differ significantly between the 2 groups when adjusted for cluster randomization (hazard ratio = 1.02, 95% CI 0.87, 1.19). Zinc and IFA supplementation compared with IFA alone did not affect adjusted hospitalization rates (overall rate ratio = 1.08, 95% CI 0.98, 1.19; diarrhea-specific rate ratio = 1.15, 95% CI 0.99, 1.34; or pneumonia-specific rate ratio = 1.09, 95% CI 0.94, 1.25). The lack of impact of zinc on mortality and hospitalization rates in this study may have been due to the use of lower daily zinc dosing than used in some of the morbidity prevention trials or from an interaction between zinc and iron, where the addition of iron may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.
Journal of Nutrition 01/2007; 137(1):112-7. · 3.92 Impact Factor
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ABSTRACT: This randomized, placebo controlled trial was designed to assess the safety and efficacy of 10-mg zinc supplementation for the treatment of acute diarrhea in infants.
A total of 1110 infants aged 28 days to 5 months with acute diarrhea were enrolled and randomized to receive either zinc (n = 554) or placebo (n = 556) for 14 days. Diarrhea history, anthropometric status, breast-feeding status and socioeconomic indicators were assessed at baseline. The homes of all infants were visited every 3 days until the diarrhea episode was over. The number of stools, presence of blood and additional illnesses were recorded daily.
The geometric mean duration of the diarrhea episode was 0.21 days longer among infants receiving zinc versus those receiving placebo, but this was not statistically significant and no difference was observed after controlling for sex, exclusive breast-feeding and length for age Z score. There were no differences in any subgroup (ie, sex, baseline length for age Z score, exclusive breast-feeding or site after controlling for the remaining subgroup variables). There were no differences in reported stool frequency or among the proportion of episodes lasting longer than 7 days. Rates of vomiting were similar in the zinc and placebo groups.
Young infants do not appear to benefit from zinc supplementation for the treatment of diarrhea.
Journal of pediatric gastroenterology and nutrition 10/2006; 43(3):357-63. · 2.18 Impact Factor
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ABSTRACT: Objective: This randomized, placebo controlled trial was designed to assess the safety and efficacy of 10-mg zinc supplementation for the treatment of acute diarrhea in infants.
Methods: A total of 1110 infants aged 28 days to 5 months with acute diarrhea were enrolled and randomized to receive either zinc (n = 554) or placebo (n = 556) for 14 days. Diarrhea history, anthropometric status, breast-feeding status and socioeconomic indicators were assessed at baseline. The homes of all infants were visited every 3 days until the diarrhea episode was over. The number of stools, presence of blood and additional illnesses were recorded daily.
Results: The geometric mean duration of the diarrhea episode was 0.21 days longer among infants receiving zinc versus those receiving placebo, but this was not statistically significant and no difference was observed after controlling for sex, exclusive breast-feeding and length for age Z score. There were no differences in any subgroup (ie, sex, baseline length for age Z score, exclusive breast-feeding or site after controlling for the remaining subgroup variables). There were no differences in reported stool frequency or among the proportion of episodes lasting longer than 7 days. Rates of vomiting were similar in the zinc and placebo groups.
Conclusions: Young infants do not appear to benefit from zinc supplementation for the treatment of diarrhea.
Journal of Pediatric Gastroenterology and Nutrition 08/2006; 43(3):357-363. · 2.30 Impact Factor
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Nita Bhandari,
Pooja Sharma,
Roger I Glass,
Pratima Ray,
Harry Greenberg, Sunita Taneja,
Manju Saksena,
C Durga Rao,
Jon R Gentsch,
Umesh Parashar,
Yvonne Maldonado,
Richard L Ward,
M K Bhan
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ABSTRACT: We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.
Vaccine 08/2006; 24(31-32):5817-23. · 3.77 Impact Factor
