Comparison of three different daily doses of vitamin D3 in the treatment of nutritional rickets in Indian children under age 5 years: A randomized controlled trial.

OBJECTIVES: To compare the efficacy of three different doses of oral vitamin D in treatment of nutritional rickets METHODS: This three-group open-labeled randomized controlled trial enrolled children age 6 months to 5 years with nutritional rickets to receive oral vitamin D3 (2000, 3000 or 4000 IU) for 12 weeks. The outcomes were final radiological rickets severity score (RSS) (primary), change in serum 25-hydroxyvitamin D (25(OH)D), calcium, phosphorus, parathyroid hormone (PTH) and alkaline phosphatase (ALP) at 12 weeks. RESULTS: A total of 132 children (68 boys) with a median (IQR) age 24 (18, 39.5) months and mean (SD) RSS 8.86 (1.89) were enrolled (44 in each of the three groups). The median (IQR) RSS improved significantly from baseline to endline RSS 2.0 (1.0, 5.0), 1.0 (0.0, 4.0) and 1.75 (0.5, 4.25); p = 0.280, in the 2000, 3000, and 4000 IU groups, respectively. The median (IQR) serum 25(OH)D levels increased at 12 weeks to 27.3 (17.7, 48.7), 38.95 (19.0, 67.6) and 46.3 (26.7, 64.6) ng/mL in 2000, 3000 and 4000 IU groups, respectively; p = 0.058. One-third children who had RSS > 1.5 had lower serum phosphorus and higher ALP at baseline (p < 0.05). Dietary calcium intake was significantly (p = 0.008) related to final log RSS irrespective of allocation group when adjusted for baseline covariates. Three children had hypercalciuria and six had serum 25(OH)D > 100 ng/mL (all belonged to the 3000/4000 IU groups). CONCLUSIONS: Daily oral vitamin D3 doses of 2000, 3000 and 4000 IU were comparable in efficacy in the treatment of nutritional rickets. CTRI: CTRI/2023/05/053097 [ https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzY0MTk=&Enc=&userName= ].