Clinical and laboratory safety of one year's use of acombination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: Results of a mlticenter, rndomized, double-blind, placebo-controlled study

Hospital Drome Nord, Romans, Rhône-Alpes, France
Clinical Therapeutics (Impact Factor: 2.73). 01/2006; 27(12):1885-93. DOI: 10.1016/j.clinthera.2005.12.010
Source: PubMed


This article presents the results of an evaluation of the clinical and laboratory safety of a 1-year course of treatment with a combination calcium and vitamin D tablet in ambulatory women aged >65 years with vitamin D insufficiency.
In a multicenter, randomized, double-blind, placebo-controlled study conducted in France, women with a 25-hydroxyvitamin D level < or =12 ng/mL were randomized to receive either a combination tablet containing calcium carbonate 500 mg and vitamin D3 400 IU taken twice daily or a matching placebo tablet for 1 year. A complete clinical examination was performed at baseline and at 3, 6, 9, and 12 months of treatment; blood and urine samples were collected for laboratory analyses at the same time points. Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests, including measurement of creatinine and uric acid levels.
The study included 192 women (mean [SD] age, 74.6 [6.9] years; mean weight, 64.0 [12.5] kg), 95 in the calcium + vitamin D group and 97 in the placebo group. Fifty women (21/95 [22.1%] calcium + vitamin D, 29/96 [30.2%] placebo) were prematurely withdrawn from the study for various reasons, with no difference in withdrawals between groups. Treatment-related adverse events were reported in 21 (22.1%) and 23 (24.0%) women in the respective treatment groups. These events consisted mainly of metabolic disorders (9 [9.5%] and 10 [10.4%], respectively), particularly hypercalcemia (6 [6.3%] and 8 [8.3%]) and gastrointestinal disorders (9 [9.5%] and 8 [8.3%]). No major complications directly related to calcium and vitamin D supplementation occurred during the course of treatment. Although renal function was not altered, the group who received calcium + vitamin D had significantly elevated concentrations of serum uric acid compared with those who received placebo (52.3% vs 37.2%; P = 0.046) but not urinary uric acid.
In these ambulatory elderly women with vitamin D deficiency, supplementation with calcium + vitamin D appeared to be well tolerated over 1 year of treatment. No significant effects on creatinine clearance were observed. However, the proportion of women with elevated serum uric acid concentrations was significantly greater in those who received calcium + vitamin D compared with those who received placebo.

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Available from: Franck Grados, Mar 21, 2015
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    • "The mean age of patients was 64.29 AE 7.88 years and 38.31% were women. One [22] of the 11 trials enrolled patients with gout, whereas the remaining 10 trials included asymptomatic patients with abnormal SUA. "
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    ABSTRACT: Background and aims: The association between serum uric acid (SUA) levels and cardiovascular (CV) risk or all-cause death has been repeatedly reported. However, it has not been assessed whether reduction of SUA levels is associated with reduced CV risk. The aim of the current study was to evaluate the relationship between changes of SUA levels and CV events as well as all-cause death. Methods and results: Randomised trials reporting SUA at baseline and at the end of follow-up and clinical end-points (all-cause death, myocardial infarction (MI), stroke, heart failure (HF) and CV death) were included in the study. Meta-regression analysis was performed to test the relationship between SUA changes and clinical end-points. Eleven trials enrolling 21,373 participants followed up for 2.02 ± 1.76 years and reporting 4533 events were included. In meta-regression analysis, no relationship between SUA changes from baseline to end of follow-up and the composite outcome including CV death, stroke, MI and HF was found (change in Tau(2) (t) = -0.64; p Tau (p) = 0.541). Similarly, no relationship was found between SUA changes and single components of the composite outcome (MI: t = -0.83; p = 0.493; stroke: t = 0.46; p = 0.667; HF: t = 2.44; p = 0.162; CV death: t = -0.54; p = 0.614) and all-cause death (t = -0.72; p = 0.496). Results were confirmed by sensitivity analysis. No heterogeneity among studies or publication bias was detected. Conclusions: Changes in SUA levels observed during pharmacologic treatments do not predict the risk of all-cause death or CV events. As SUA levels are associated with increased CV risk, additional studies with direct xanthine-oxidase inhibitors are requested.
    Nutrition, metabolism, and cardiovascular diseases: NMCD 05/2013; 23(8). DOI:10.1016/j.numecd.2013.03.001 · 3.32 Impact Factor
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    • "Response to Treatment : Patients initially showed significant clinical improvement after treatment with vitamin D and calcium.31 However, follow up was inefficient because we could not obtain relevant information for assessing the clinical and biochemical response to long-term treatment. "
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    ABSTRACT: Objective: We aimed to investigate the associations between the neurological manifestations of vitamin D deficiency and bone profile as well as the levels of 25-hydroxyvitamin D. Methodology: We conducted a case series on patients with vitamin D deficiency who were followed up at King Abdulaziz Medical City, Jeddah between January 2010 and December 2011. We collected patients’ demographic data and gathered information on etiological factors for vitamin D deficiency as well as clinical presentations (typical, neurological and rheumatological) and radiological findings. The t-test was used to determine whether there was an association between the neurological manifestations of vitamin D deficiency and vitamin D levels and bone profile. Results: We enrolled 60 patients with vitamin D deficiency. Of these, 44 (73.3%) had neurological presentations, namely progressive muscle weakness and proximal weakness, which was observed more often than distal weakness. In addition, gait disturbances were observed in 61.7% of all patients with neurological and rheumatological presentations. There was no significant association between neurological and rheumatological manifestations and bone profile or vitamin D levels. We found a significant association between difficulty in walking and the levels of serum calcium and phosphate (P = 0.043 and 0.037, respectively). Conclusion: Neurological and rheumatologic manifestations of vitamin D deficiency are not associated with 25-hydroxyvitamin D levels or bone profile.
    Pakistan Journal of Medical Sciences Online 05/2013; 29(3):735-9. · 0.23 Impact Factor
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    • "Therefore, an intensive trial study is needed to determine whether vitamin D supplementation can reduce SUA in hyperuricemia. Recently, in contrast, a small clinical trial [25] which enrolled 192 women ≥65 years and found that the group who received both calcium and vitamin D had significantly elevated concentration of SUA (316.5 umol/L vs 291.0 umol/L) compared with those who received placebo. "
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    ABSTRACT: Association between vitamin D insufficiency and hyperuricemia has not been reported so far. We aimed to study the association of vitamin D insufficiency with elevated serum uric acid among middle-aged and elderly Chinese Han women. We collected data from participants residing in Jinchang district of Suzhou from January to May, 2010. Serum uric acid, 25-hydroxy vitamin D and other traditional biomarkers including fasting plasma glucose and blood lipids were determined in 1726 women aged above 30 years. Association between vitamin D insufficiency and elevated uric acid was analyzed in premenopausal and postmenopausal women, respectively. Among postmenopausal women, 25-hydroxy vitamin D level of participants with elevated uric acid was lower than that of those with normal uric acid (median [interquartile range]: 35[28-57] vs 40[32-58], µg/L; P = 0.006). Elevated uric acid was more prevalent in participants with vitamin D insufficiency compared to those without vitamin D insufficiency (16.50% vs 8.08%; P<0.001). Association between vitamin D insufficiency and elevated uric acid was not significant among premenopausal women. However, participants with vitamin D insufficiency were more likely to have elevated uric acid compared with those without vitamin D insufficiency among postmenopausal women (OR, 95% CI: 2.38, 1.47-3.87). Moreover, after excluding individuals with diabetes and/or hypertension, the association of vitamin D insufficiency with elevated uric acid was still significant (OR, 95% CI: 2.48, 1.17-5.44). Vitamin D insufficiency was significantly associated with elevated uric acid among postmenopausal Chinese Han women. This study suggested that a clinical trial should be conducted to confirm the association of vitamin D insufficiency with hyperuricemia.
    PLoS ONE 04/2013; 8(4):e61159. DOI:10.1371/journal.pone.0061159 · 3.23 Impact Factor
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