Oral Vitamin D Supplementation to Mothers During Lactation- Effect of 25(OH)D Concentration on Exclusively Breastfed Infants at 6 Months of Age: A Randomized Double-Blind Placebo-Controlled Trial

Background: Exclusively breastfed infants are at risk of vitamin D deficiency. Objective: To find out proportion of exclusively breastfed infants having serum 25(OH)D concentration Methods: Randomized placebo-controlled study included 132 mothers and infants divided into two groups. Mothers received either vitamin D-3 60,000 IU between 24 and 48 hours postpartum and at 6, 10, and 14 weeks amounting to 240,000 IU of vitamin D-3 or placebo. Serum 25(OH)D concentration in the mothers was measured at recruitment and that of infants, at birth and 6 months. Infants were evaluated for rickets at 6 months. Findings: Total 114 mother-infant dyads followed. Subjects in both groups were comparable in basic characteristics. At 6 months of age, serum 25(OH)D concentration in infants was 18.93 (5.12) ng/mL in the intervention group and 6.43 (3.76) ng/mL in the control group (mean difference = 12.5; 95% CI = 10.80-14.17; p < 0.001) and vitamin D deficiency and insufficiency was corrected in 93.1% and 38% infants, respectively, in the intervention group. There was no change in the vitamin D status of infants in the control group. In 60.3% infants (RR = 0.519; 95% CI = -0.485 to 0.735) of the intervention group 25(OH)D concentration was Conclusion: Serum 25(OH)D concentration of exclusively breastfed infants rise significantly when mothers are orally supplemented with 240,000 IU of vitamin D-3 during lactation in comparison with the infants of unsupplemented mothers with 94.6% and 48.1% reduction in the risk of vitamin D deficiency and insufficiency, respectively, at 6 months of age.