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Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.

Archives of disease in childhood (2014-04-22)
Tom D Thacher, Philip R Fischer, John M Pettifor
ABSTRACT

To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone. Randomised controlled trial. Jos University Teaching Hospital, Jos, Nigeria. Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks. Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L. The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values <30 nmol/L. Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status. Of the 68 children (94% of original cohort) who completed 24 weeks of treatment, 29 (67%) in the Ca+D group and 11 (44%) in the Ca group achieved the primary outcome (p=0.06). Baseline 25(OH)D did not alter treatment group effects (p=0.99 for interaction). At the end of 24 weeks, 25(OH)D values were 55.4±17.0 nmol/L and 37.9±20.0 nmol/L in the Ca+D and Ca groups, respectively, (p<0.001). In the Ca+D and Ca groups, the final 25(OH)D concentration was greater in those who achieved the primary outcome (56.4±17.2 nmol/L) than in those who did not (37.7±18.5 nmol/L, p<0.001). In children with calcium-deficiency rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations. ClinicalTrials.gov NCT00949832.

MATERIALS
Product Number
Brand
Product Description

Supelco
Ergocalciferol (Vitamin D2), Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Ergocalciferol, ≥98.0% (sum of enantiomers, HPLC)
Sigma-Aldrich
Ergocalciferol, 40,000,000 USP units/g
Ergocalciferol, European Pharmacopoeia (EP) Reference Standard
Supelco
Vitamin D2 solution, 1 mg/mL in ethanol, ampule of 1 mL, certified reference material, Cerilliant®
USP
Ergocalciferol, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Vitamin D2 solution, 100 μg/mL in ethanol, 98% (CP)