Abstract
Objective:
To compare the efficacy of sunlight exposure and oral vitamin D3 supplementation to achieve vitamin D sufficiency in infants at 6 months of age.
Design:
Open-label randomized controlled trial.
Setting:
Public hospital in Northern India (28.7°N).
Participant:
Breastfed infants at 6-8 weeks of age.
Intervention:
Randomized to receive sunlight exposure (40% body surface area for a minimum of 30 minutes/week) or oral vitamin D3 supplementation (400 IU/day) till 6 months of age.
Outcome:
Primary - proportions of infants having vitamin D sufficiency (> 20 ng/mL) Secondary - Proportion vitamin D deficiency (<12ng/mL), and rickets in both the groups at 6 months of age.
Results:
Eighty (40 in each group) infants with mean (SD) age 47.8 (4.5) days were enrolled. The proportion of infants with vitamin D sufficiency increased after intervention in the vitamin D group from 10.8% to 35.1% (P=0.01) but remained the same in sunlight group (13.9%) and was significant on comparison between both groups (P=0.037). The mean (SD) compliance rate was 72.9 (3.4) % and 59.7 (23.6) % in the vitamin D and sunlight group, respectively (P=0.01). The geometric mean serum 25(OH)D levels in the vitamin D and sunlight group were16.23 (95% CI: 13.58-19.40) and 11.89 (95% CI: 9.93-14.23) ng/mL, respectively; P=0.02, after adjusting baseline serum 25(OH)D with a geometric mean ratio of 1.36 (1.06-1.76). Two infants in sunlight group developed rickets.
Conclusions:
Oral vitamin D3 supplementation is more efficacious than sunlight in achieving vitamin D sufficiency in breastfed infants during the first 6 months of life due to better compliance.
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