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Effects of Zinc Supplementation in Occurrence and Duration of Common Cold in School Aged Children During Cold Season: a Double-Blind Placebo-Controlled Trial

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Objective: Zinc deficiency is common in children in developing countries due to low intake of animal foods, and high dietary phytate content. Zinc deficiency impairs overall immune function and resistance to infection. The effect of zinc on the common cold is still questionable. To determine whether supplementation of zinc could reduce frequency rate and duration of common cold during cold season in school aged children living in a low socioeconomic suburb of Mashhad (Altimor), north-east Iran. Methods: We designed a randomized double-blind, placebo-controlled efficacy trial. Subjects were 200 grade 2 primary school children who all completed the trial. Intervention supplementation was zinc sulfate tablets (10 mg elemental) and placebo tablets for case and control groups, respectively. Tablets were taken on a daily basis, 6 days a week, for 5 months (November to March). Findings: Among the zinc-supplemented group common cold incidence of 1.37±0.86 episodes per child during the study period was recorded in comparison to 3.15±0.55 cold episodes per child among the placebo group (P<0.001). Mean overall missing days from school was 0.55±1.09 days and 1.35±1.79 days for zinc-supplemented and placebo groups, respectively. The need for administration of antibiotics for bacterial infections (pharyngitis, acute otitis media, sinusitis, pneumonia) were 20 and 47 courses for zinc-supplemented and placebo groups, respectively (P<0.01). Conclusion: This study showed that zinc supplementation has a beneficial impact on the occurrence of common cold.
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* Corresponding Author;
Address: DepartmentofPublicHealthHealthfacultyMashhadUniversityofMedicalsciences,Mashhad,Iran
E-mail:vahedianm@mums.ac.ir
©2009byPediatricsCenterofExcellence,Children’sMedicalCenter,TehranUniversityofMedicalSciencs, Allrightsreserved.
EffectsofZincSupplementationinOccurrenceandDurationof
CommonColdinSchoolAgedChildrenduringColdSeason:a
DoubleBlindPlaceboControlledTrial
RahimVakili1,MD;MohammadVahedian*2,MCs;GholamHossianKhodaei3,PharmMD;
MahmoudMahmoudi4,MD
1. DepartmentofPediatrics,MashhadUniversityofMedicalSciences,Mashhad,Iran
2. DepartmentofPublicHealth,MashhadUniversityofMedicalSciences,Mashhad,Iran
3. ProvinceHealthCenter,MashhadUniversityofMedicalSciences,Mashhad,Iran
4. ImmunologyResearchCenter,MashhadUniversityofMedicalSciences,Mashhad,Iran
Received:Nov25,2008;FinalRevision:Mar17,2009;Accepted:Aug23,2009
Abstract
Objective:Zinc deficiencyiscommoninchildrenindeveloping countriesduetolowintakeof
animal foods, and high dietary phytate content. Zinc deficiency impairs overall immune
functionandresistancetoinfection.Theeffectofzinconthecommoncoldisstillquestionable.
To determine whether supplementation of zinc could reduce frequency rate and duration of
commoncoldduringcoldseasoninschoolagedchildrenlivinginalowsocioeconomicsuburb
ofMashhad(Altimor),north‐eastIran.
Methods:We designed a randomized double‐blind, placebo‐controlled efficacy trial. Subjects
were200grade2primaryschoolchildrenwhoallcompletedthetrial. Intervention
supplementation was zinc sulfate tablets (10 mg elemental) and placebo tablets for case and
controlgroups,respectively.Tabletsweretakenonadailybasis,6 days a week, for 5 months
(NovembertoMarch).
Findings:Amongthe zinc‐supplemented groupcommoncoldincidenceof 1.37±0.86 episodes
perchildduringthestudyperiod was recorded in comparison to 3.15±0.55 cold episodes per
child among the placebo group (P<0.001). Mean overall missing days from school was
0.55±1.09 days and 1.35±1.79 days for zinc‐supplemented and placebo groups, respectively.
The need for administration of antibiotics for bacterial infections (pharyngitis, acute otitis
media, sinusitis, pneumonia) were 20 and 47 courses for zinc‐supplemented and placebo
groups,respectively(P<0.01).
Conclusion:Thisstudyshowedthatzincsupplementationhasabeneficialimpact on the
occurrenceofcommoncold.
IranianJournalofPediatrics,Volume19(Number4),Dec2009,Pages:376380
KeyWords:ZincSupplementation;Commoncold;UpperrespiratoryInfection;Children
Original Article
Iran J Pediatr
Dec 2009; Vol 19 (No 4), Pp:376-380
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Iran J Pediatr; Vol 19 (No 4); Dec 2009
Introduction
Zincisanessentialmicronutrientforhuman
growth, development, and immune function.
Mild to moderate zinc deficiency can be best
detectedthroughapositiveresponseto
supplementation trials. Zinc supplementation
hasbeen shown tohave a positiveeffect on the
incidenceofdiarrhea,andpneumonia[1].
Upper respiratory tract viral infections are
one of the most common reasons for physician
visits.Schoolagedchildrenmayexperience6to
8coldsperyear[2].Inchildren,thisillnessisalso
moreextensivethaninadultsandusually
requires medical attention. Statistics indicate
thatmorethan 80% of commoncoldsrequiring
medical attention affect children and
adolescents[3].
Zinc salts have been found to inhibit
rhinovirus replication invitro, possibly by
interferingwithrhinovirusproteincleavage[4].It
has also been suggested that cold symptoms,
sneezingandnasalcongestion,mightbereduced
byelevationsinintranasalzincsalts,producinga
chemicalclamp,ormaybeduetocorrectionofa
subclinicalzincdeficiency[5,6].
Several controlled trials of treatment of
common cold with zinc have been published;
however,there are onlyafewcommunity‐based
longitudinal studies that have been conducted
with zinc supplementation for prevention of
commoncoldduringcoldseason[7].
To investigate the effect of zinc supplemen‐
tation on the prevention of occurrence and the
needforantibioticadministration,weperformed
anintervention trial among school aged Iranian
childreninsuburbofMashhad.
SubjectsandMethods
The study was a randomized, double‐blind,
placebo‐controlled, community‐based inter‐
vention trial conducted between November
2004 and March 2005 in Altimor suburb of
Mashhad,northeastIran.Theprojectwas
approved by the scientific advisory and ethical
committees of Mashhad University of Medical
Sciences.Writteninformedconsentformswere
signed by the parents before including the
children in the study. For ethical reasons and
limitationofcostwedidnotmeasureplasma
Zinklevelsinthisstudy.
A total of 200 children (aged 78 to 120
months) were randomly assigned to daily (6
days in week) supplementation with 10 mg
elementalzincasatablet(n=100,50males, and
50females),orplacebo(n=100,50males,and50
females).
Foreachchildthatwasenrolledinthestudy,a
standardized questionnaire was completed to
obtain family details including basic
demographic and socioepidemiologic data. The
subjects were free of chronic diseases, such as
sickle cell disease, or protein‐energy
malnutrition. All participants were observed on
adaily basis for any medicalsign and symptom
especiallycoldsymptoms.Thisdailysurveillance
for the detection of any sign and symptom of
common cold and other possible diseases was
conductedbytrainedhealthworkers.
These workers were also responsible for
proper administration of the zinc or placebo
tablets. Regular field visits (once a week) for
additionaldata collectionandsupervisionofthe
health workers were made by our physician.
Commoncoldwas defined as thepresence of at
least two of the following symptoms: cough,
headache, hoarseness, muscle ache, nasal
drainage,nasalcongestion,scratchythroat,sore
throat,sneezing,andfever.
Data were analyzed using statistical software
packagesSPSSll.5(SPSS,Inc,Chicago,IL)and
EpiInfo(CenterforDiseaseControland
Prevention,Atlanta, GA) using the χ2 test,t‐test
and ANOVA, P values less than 0.05 was
consideredstatisticallysignificant.
Findings
Table l summarizes the demographic charac‐
teristicsofparticipants.Theaverageoccurrence
ofcommoncoldwas1.73±0.86inzincrecipients
and3.15±0.55inplaceborecipients(P<0.001)
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ZincSupplementationandDurationofCommonCold; R Vakili, et al
Table1:Demographicfindingsof200studentstreatedwithzincsulfateorPlacebo
VariableZincgroupPlacebogroup
Pvalue
Age(month)
Mean(SD*) 93.7(7.38) 93.1(7.35) 0.09
SexMale
Female
50
50
50
50
Numberoffamily
members4.7(2.2) 4.5(2.1) 0.7
SmokerParent18 19 0.1
*SD:StandardDeviation
(Table2).Missingdaysfromschoolduring5
months of study were 0.55±1.09 days (per
student) and 1.35±1.79 days (per student) in
zinc‐supplemented and control groups,
respectively (P<0.001). In the zinc‐
supplemented group, three participants
complained from mild gastrointestinal
discomfortwhichwasresolvedwithinfewdays
andtherewasnoneedfortheirexclusionfrom
thestudy.
Discussion
Millions of people throughout the world may
haveinadequatelevelsofzincintheirdietdueto
limited access to zinc‐rich foods (animal
products,oystersandshellfish)andthe
abundance of zinc inhibitors such as phytate,
commoninplant‐baseddiets[8].
Zinc is a key component of the cell
architectureandisrequiredfortheproduction
ofover200enzymesincludingphosphatase,
metalloproteinases, oxidoreductase, and
transferase which are involved in protein
synthesis,nucleicacid metabolism, and immune
function[18].Zincdeficiency is commonin young
children in the developing countries and is
associated with reduced immuno‐competence
and increased rates of serious infectious
diseases[9].Severalstudieshaveshownthatzinc
supplementation has a positive influence on
linear,motordevelopmentandweightgain[19].
Community‐based studies conducted among
childrenofdifferentage groups have shown the
beneficialimpact of zinc supplementationinthe
form of reduced diarrhea episodes in children
with zinc deficiency, since this supplementation
maylead toacceleratedregeneration ofmucosa,
increased levels of brush border enzymes,
enhancedcellularimmunity,andhigherlevels of
secretoryantibodies[10].
Table2: Mediancommoncoldoccurrenceneedforantibioticmissingschool
Among200StudentsTreatedwithZincsulfateorPlacebo
VariableZincgroupPlacebogroupPvalue
Averagecommoncold
occurrence(SD)
Max
Min
1
.7(0.86)
6
0
3.1(0.55)
8
0
<0.001
Needforantibiotic
administration20 47 <0.001
Daysmissingschool0.55±1.09 1.35±1.79 <0.001
*SD:StandardDeviation
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Iran J Pediatr; Vol 19 (No 4); Dec 2009
Wefoundthatsupplementationwithzincwas
associated with a decrease in the average
occurrence of commoncold duringcold months
of year, among children living in suburbs of
Mashhadwithlowsocioeconomicstatus.Wealso
found that supplementation with zinc was
associated with a decrease in the average
durationandseverityofcommoncold.
Prasad and coworkers showed a beneficial
effectof zinclozenges for reduction of duration
and severity of cold symptoms[7]. They believed
improvement in cold symptoms was related to
the antioxidant anti–inflammatory effect of
zinc[19].
However, previous trials failed to show a
beneficialeffectofzincfortreatmentofcommon
cold, perhaps because inadequate doses or
inappropriate formulations of zinc were used,
resulting in lack of bioavailable zinc[11,12]. Three
other double‐blind placebo‐controlled trials
evaluated the prophylactic and therapeutic
efficacyofzincgluconateglycinelozenges.Inthe
first study involving 57 volunteers,
administrationofzincgluconatelozenge(23mg
every 2 hours for 4.5 days) started one day
before inoculation with human rhinovirus,
reducedthetotalmeanclinicalscoreto5.7from
8.2 with placebo[13,14].Inanotherstudy69
subjectswereinoculatedwithhumanrhinovirus,
andthe12whoexperiencedcoldsymptomwere
randomly allocated to receive either zinc
gluconate lozenges or matched placebo every 2
hoursfor6dayswhileawake.Onceagainzinc
treatment significantly reduced clinical scores
compared to placebo[15]. Retrospective chart
analysis study by McElroy and coworkers
providesstrongsupportforthebeneficialeffects
of zinc in school‐aged subjects with common
cold. They concluded that treatment with zinc
canreducedurationofcoldsigns andsymptoms
and the need for antibiotics, and prophylaxis
maydecreasetheincidenceofcolds
[16]. Hulisz
showedthatzincadministrationwithin24hours
of the onset of common cold may reduce the
duration and severity of symptoms of common
cold[17].According toAmericanFamilyPhysician
guidelinezincisnotrecommendedfortreatment
of common cold because of these inconsistent
studyresults[20].
In our study only 20 participants in zinc
supplementation group required antibiotics for
treatment of upper respiratory tract infection
compared to 47 individuals that needed
antibiotictherapyinplacebogroup.
Recently, Kurugol and coworkers carried out a
prospectivestudytodeterminetheprophylactic
andtherapeuticeffectivenessofzincsulphatefor
the common cold in children. The results of the
study showed that the use of zinc sulphate
significantly reduced the risk of colds andcold‐
relatedschoolabsences[3].
Conclusion
Inconclusionweshowedthatsupplemen‐tation
with zinc was associated with significant
decreaseofthefrequencyofcolds,andreduction
inthedurationandseverityofthesymptomsof
common cold. In addition, the need for use or
misuseofantibioticswasreduced.
Fortification of more commonly used foods
such as bread with zinc salts may be beneficial.
However,furtherinvestigationisrequired.
Acknowledgment
Thisstudy wassupportedbygrantNo. 83047of
vicepresidentforresearch,MashhadUniversity
ofMedicalSciences.Participationofthechildren
andtheirparentsisalsoacknowledged.
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Following a tolerance study, double-blind placebo controlled trials were conducted to determine the prophylactic effect of zinc gluconate lozenges on rhinovirus challenge and, in a third study, their therapeutic efficacy when given at the start of colds caused by virus inoculation was tested. In the prophylaxis study a total of 57 volunteers received lozenges of either zinc gluconate (23 mg) (29 volunteers) or matched placebo (28 volunteers) every 2 h while awake during a period of four and a half days. They were challenged with 10² tissue culture infecting dose (TCID50) of human rhinovirus 2 (HRV-2) on the second day of medication, and were monitored daily for symptoms and signs of colds and laboratory evidence of infection. Zinc reduced the total mean clinical score from 8.2 in the placebo group to 5.7 and the reduction of the mean clinical score was statistically significant on the second day after virus challenge. In the therapeutic study 69 volunteers were inoculated with 10² TCID50 of HRV-2 and those who developed cold symptoms were randomly allocated to receive either zinc gluconate lozenges (six volunteers) or matched placebo lozenges (six volunteers) every two hours they were awake for six days. Treatment of colds with zinc reduced the mean daily clinical score and this was statistically significant on the fourth and fifth day of medication. Similarly, medication also reduced the mean daily nasal secretion weight and total tissue count and these reductions were statistically significant on days two and six for nasal secretion weights and days four to six of medication for tissue counts when compared with placebo. There were also statistically significant reductions in the mean total nasal secretion weights and total tissue counts. Zinc, however, had no significant effect on the rate or amount of virus excreted by volunteers. We conclude that zinc gluconate lozenges are reasonably well tolerated and that they have a significant effect on the signs and symptoms of colds caused by rhinoviruses, although the mechanism of action remains obscure.
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Zinc is essential for all species. Human zinc deficiency related to diet was recognized 30 yr ago among adolescents in Iran and Egypt. Subsequent factorial calculations, balance studies, and tracer studies of bioavailability and turnover established the amounts of zinc needed for equilibrium and dietary factors that impair retention. Comparison of dietary intakes of zinc with requirements suggested many women and children are at risk of deficiency. Epidemiological studies associated low plasma levels of zinc with abnormal pregnancy outcomes and controlled intervention trials showed that zinc repletion improved pregnancy outcomes. Low iron nutriture, a common phenomenon in women, was shown to be associated with low zinc nutriture. Thus the hypothesis that zinc deficiency is a public health problem appears to be true.
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Clinical studies have shown that ionic zinc (Zn2+) dissolved in the mouth shortened manifestations of the common cold significantly, by an unknown mechanism. The observed immediate effect on symptoms is consonant with osmotic transport of Zn2+, placing a temporary chemical clamp on critical nerves. It is proposed that transient elevation of Zn2+ concentration in and around the nasal cavity facilitates Zn2+ complexation with known intercellular adhesion molecule binding sites on rhinovirus surfaces which prevents rhinovirus binding to cells and interrupts infection. The crystallographically determined surface of rhinovirus-14 has been found to contain binding sites for at least 360 Zn2+. Such binding of Zn2+ would be stabilized by numerous histidine, methionine, tyrosine and carboxyl/carboxylate groups known to line the HRV-14 surface canyons. The resulting blockage of HRV docking with intercellular adhesion molecule binding sites is proposed to be responsible for the observed reduction of the duration of colds by statistically significant and clinically meaningful times.
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Due to dietary modifications including the intake of cereals, vegetables and the frequent use of soy milk instead of breast milk, children in developing countries with diarrhea frequently suffer from zinc deficiency. Furthermore, diarrhea leads to excess zinc losses. Beside low energy intake zinc deficiency contributes to continued diarrhea, which in turn accounts for half of the deaths from diarrhea in children. Zinc supplementation leads to accelerated regeneration of the mucosa, increased levels of brush-border enzymes, enhanced cellular immunity and higher levels of secretory antibodies. In addition, in stunted children zinc supplementation results in enhanced catch-up growth via higher levels of insulin-like growth factor-I. Growth retardation is closely related to the risk of diarrheal diseases in children. These pathophysiological conclusions are supported by several controlled clinical traits which have provided evidence that zinc supplementation results in significant reduction in the risk of continued diarrhea. However, it remains to be clarified whether these benefits are attributable to pharmacological effects or if they can be related to the correction of an underlying deficiency state.