Impact of three different daily doses of vitamin D₃supplementation in healthy schoolchildren and adolescents from North India: a single-blind prospective randomised clinical trial

Abstract

In India, there is a lack of information about the adequate daily dose of vitamin D3 supplementation in school children. Hence, we undertook this study to evaluate the adequacy and efficacy of different doses of vitamin D3 in schoolchildren. A total of 1008 vitamin D-deficient (VDD) children, aged 6–16 years with serum 25-hydroxyvitamin D (25(OH)D) levels <50nmol/l, were cluster randomised into three groups (A-344, B-341 and C-232) for supplementation (600, 1000 and 2000 IU daily) of vitamin D3 under supervision for 6 months. Of the 1008 subjects who completed the study, 938 (93 %) were compliant. Baseline and post-supplementation fasting blood and urine samples were evaluated for Ca, phosphates, alkaline phosphatase, 25(OH)D and parathormone and urine Ca:creatinine ratio. The mean age of the subjects was 11·7 (sd 2·4) years, and the overall mean baseline serum 25(OH)D level was 24·3 (SD 9·5)nmol/l. Post-supplementation rise in serum 25(OH)D in compliant group was maximum with 2000 IU (70·0 (SD 30·0)nmol/l), followed by 1000 IU (46·8 (SD 22·5)nmol/l) and 600 IU (36·5 (SD 18·5)nmol/l), and serum 25(OH)D levels of ≥50nmol/l were achieved in 71·5, 81·8 and 92·9 % by groups A, B and C, respectively. Secondary hyperparathyroidism decreased from 31·7 to 8·4 % post-supplementation. Two participants developed hypercalciuria, but none developed hypercalcaemia. Children with VDD benefit maximum with the daily supplementation of 2000 IU of vitamin D3. Whether recommendations of 400 IU/d by Indian Council of Medical Research or 600 IU by Indian Academy of Pediatrics or Institute of Medicine would suffice to achieve vitamin D sufficiency in children with VDD remains debatable.

Reference range of random urinary calcium creatinine ratio in North Indian children and adolescents

“…1). 31) There were 702 children and adolescents who achieved serum 25OHD value of ≥50 nmol/L with serum PTH of <65 ng/L. Of these, 229 had dietary calcium intake less than the recommended daily allowance (RDA) as per the Indian Council of Medical Research (ICMR)34); these subjects were excluded from the study.…”

“…Vitamin D supplementation is known to increase UCaCrR in vitamin D deficient children and adolescents. 30,31) However, UCaCrR is not affected in vitamin D sufficient children and adolescents. 32,33) Hence, vitamin D status is an important determinant of UCaCrR.…”

Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia

“…This research is innovative considering that there are few studies on adolescent and young adult populations and that these have not been carried out in Latin America. [ 14 , 15 ] Consequently, if this trial provides positive results, it will be possible to recommend oral vitamin D supplementation for the reduction of BMI and lipid profile in the studied population. In addition, it is a low-cost and easy-to-apply intervention that could contribute to the formulation and implementation of health policies.…”

“…Studies on the effect of supplementation in adolescents and young adults are scarce; however, the favorable effect of supplementation in the serum levels of 25 (OH) D in school-age children with VDD and the reduction in blood pressure, the concentration of fasting glucose, and improvements in sensitivity to insulin in children with overweight and obesity is widely known. [ 14 , 15 ] Notwithstanding this, more clinical trials are required to confirm these findings.…”

“…Likewise, Marwaha et al, showed that VD supplementation with the three daily doses of vitamin D3 (600, 1000, and 2000 IU) lead to a significant increase on the serum levels of 25 (OH) D in school children with VDD and the secondary hyperparathyroidism decreased from 31.7% to 8.4% after supplementation. [ 15 ]…”