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 <11 ng/mL at 6 months of age with or without oral supplementation of vitamin D3 to lactating mothers. Methods: Randomized placebo-controlled study included 132 mothers and infants divided into two groups. Mothers received either vitamin D3 60,000 IU between 24 and 48 hours postpartum and at 6, 10, and 14 weeks amounting to 240,000 IU of vitamin D3 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 <20 ng/mL at 6 months of age. Six infants in the control group suffered from biochemical rickets. Radiological rickets developed in one infant in the intervention group and two infants in the control group. Conclusion: Serum 25(OH)D concentration of exclusively breastfed infants rise significantly when mothers are orally supplemented with 240,000 IU of vitamin D3 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.
Keywords: breastfeeding; infants; lactation; rickets; vitamin D supplementation.