Low dose depot oral vitamin D3v. daily oral vitamin D3 for treating nutritional rickets: a randomised clinical trial.

Abstract

We aimed to compare the efficacy of daily v. low dose depot oral vitamin D3 for treating nutritional rickets. We conducted a randomised controlled trial in the department of paediatrics of a tertiary care hospital catering to semi-urban and rural population in Delhi, India. We randomised sixty-six children aged 3 months to 5 years with nutritional rickets to receive either daily oral vitamin D3 drops (3-12 months: 2000 IU; > 12 months to 5 years: 4000 IU; n 33) for 12 weeks duration or a single oral depot dose of vitamin D3 granules (3-12 months: 60000 IU; > 12 months to 5 years: 150000 IU; n 33). Participants in both groups had comparable demographic characteristics, laboratory features and radiological severity of rickets. Thirty-three participants in each group received the assigned intervention and all were followed up till 12 weeks. At 12 weeks follow-up, children in both groups showed a significant improvement in all biochemical parameters (serum Ca, P, alkaline phosphatase (ALP), parathormone and 25(OH) vitamin D levels) as well as radiological healing. At 12 weeks, the mean serum 25(OH) vitamin D levels (nmol/l) were statistically comparable in both groups (daily: 120·2 (sd 83·2), depot: 108 (sd 74), P = 0·43) and 31 (93·9 %) children in each group had radiological healing (Thacher score < 1·5). Two children in each group persisted to have raised ALP, and one child each in the daily group continued to have hypocalcaemia and hypophosphataemia at 12 weeks. Low dose oral depot vitamin D3 is an effective alternative to daily oral vitamin D3 for nutritional rickets.