Skeletal muscle strength in young Asian Indian females after vitamin D and calcium supplementation: a double-blind randomized controlled clinical trial.
What this study found
Oral calcium and/or cholecalciferol did not improve skeletal muscle strength, physical performance, or quality of life over 6 months. Handgrip strength showed no significant between-group difference (P=0.19), and pinch strength, 6-minute walk distance, dyspnea VAS, and SF-36 physical and mental component scores were also non-significant. Although supplementation increased vitamin D status and was generally well tolerated, hypercalciuria and hypercalcemia occurred across arms without significant group differences, including 2 cases of severe hypercalcemia.
- Study & population
- Randomized, double-blind, placebo-controlled factorial trial in young, apparently healthy vitamin D-deficient Asian Indian women recruited at All India Institute of Medical Sciences, Delhi, India.
- Intervention
- This double-blind factorial trial evaluated three oral active regimens over 6 months: calcium carbonate 500 mg elemental calcium twice daily, cholecalciferol 60,000 IU weekly for 8 weeks followed by 60,000 IU every 2 weeks for 4 months, or the combination of both regimens.
- Key limitation
- Each active arm was modest in size (n=43), which limits power to detect small effects or uncommon harms.
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Open PDFOriginal abstract
CONTEXT Randomized control trials (RCT) of the effect of vitamin D/calcium supplementation on skeletal muscle strength have not shown promising effect in the elderly. OBJECTIVE Our objective was to assess the effect of vitamin D and/or calcium on muscle strength in young adults with vitamin D deficiency. DESIGN AND SETTING We conducted a RCT using a factorial design at a tertiary-care center from September 2010 to April 2011. SUBJECTS A total of 173 healthy females with mean age, body mass index, and 25-hydroxyvitamin D [25(OH)D] of 21.7 ± 4.4 yr, 20.8 ± 2.96 kg/m(2), and 9.3 ± 3.37 ng/ml, respectively, were block randomized to 1) double placebo, 2) calcium/placebo, 3) cholecalciferol/placebo, and 4) cholecalciferol/calcium for 6 months. Cholecalciferol was given at 60,000 IU/wk for 8 wk followed by 60,000 IU/fortnight. Elemental calcium was given in doses of 500 mg twice per day for 6 months. METHODS Assessment included hand grip (primary outcome) and pinch grip strength, distance walked in 6 min, dyspnea score, quality of life by Short Form (36) Health Survey (SP-36), serum 25(OH)D, 1,25-dihydroxyvitamin D, and intact PTH. RESULTS The serum 25(OH)D increased significantly to 29.9 ± 8.35 and 27.0 ± 9.54 ng/ml in two groups on cholecalciferol. The mean hand grip strength (19.4 ± 3.92, 21.1 ± 3.31, 20.6 ± 3.92, and 20.1 ± 4.00 kg) and its increase from baseline (0.3 ± 2.25, 0.3 ± 2.64, -0.3 ± 2.41, and 0.6 ± 2.30 kg) were comparable in four groups at 6 months. Quality of life, urinary calcium/creatinine ratio, and adverse effects were also comparable in groups. CONCLUSION Oral cholecalciferol/calcium supplementation in the dose/schedule used is effective and safe in increasing and maintaining serum 25(OH)D. However, this does not lead to improved skeletal muscle strength in young females.