Efficacy of 800 IU Versus 400 IU Daily Oral Vitamin D3 Supplementation for Vitamin D Insufficiency Among Term Small-for-Gestational Age Breastfed Infants: An Open Label Randomized Controlled Trial.

OBJECTIVE: in reducing the incidence of vitamin D insufficiency (VDI) (serum 25-OH-D 100 ng/mL). RESULTS: Among 60 enrolled infants, the distribution of baseline variables was similar in both groups. The proportion of infants with VDI at 14 weeks was significantly less in 800 IU (30%) versus 400 IU (63.3%) group (RR = 0.47, 95% CI 0.18, 0.73; P = 0.016). In the 800 IU group, there was a trend towards reduction in the proportion of infants with VDD, and no infant with severe VDD. Clinical rickets was seen in 3 infants (1 in 800 IU and 2 in 400 IU), with all having VDD. None of the infants had VDT. CONCLUSION: in exclusively breastfed term SGA infants significantly reduced the proportion of infants with vitamin D insufficiency without any toxicity. Trial registry CTRI/2023/08/071999.