Efficacy and Safety of 90,000 IU versus 300,000 IU Single Dose Oral Vitamin D in Nutritional Rickets: A Randomized Controlled Trial.

AIM

To compare efficacy and safety of 90,000 IU versus 300,000 IU oral single dose vitamin D for treatment of nutritional rickets.

STUDY DESIGN

Randomized controlled trial.

SETTING

Tertiary care hospital.

PARTICIPANTS

One hundred ten children (6 months to 5 years, median age 10.5 months) with rickets. Exclusion criteria were disease affecting absorption, intake of calcium/vitamin D preparation in last 6 months, abnormal renal function, and rickets other than nutritional.

INTERVENTION

Vitamin D3 as a single oral dose 90,000 IU (group A, = 55) or 300,000 IU (group B, = 55).

METHODOLOGY

Severity of rickets was scored on knee and wrist X-ray as per Thacher's radiographic score. Baseline serum levels of calcium, SAP, 25(OH)D, iPTH were measured. Follow up was done at 1 week, 4 weeks, and 12 weeks.

OUTCOME VARIABLE

Primary - Radiographic score at 3 months. Secondary - Serum levels of 25(OH)D, SAP, and iPTH at 3 months, clinical and biochemical adverse effects.

RESULTS

Eighty-six subjects (43 in each group) completed the study. The radiographic score reduced from 6.90 to 0.16 in group A and from 6.93 to 0.23 in group B. The levels of 25(OH)D, ALP, and PTH were similar between the groups at baseline and follow up. Hypercalciuria and hypercalcemia were seen more often in group B as was hypervitaminosis D. There were no clinical adverse events.

CONCLUSIONS

Single oral dose vitamin D3 90,000 IU is safe and effective in achieving healing of rickets.