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 — proportion of infants having vitamin D sufficiency (>20 ng/mL). Secondary — proportion of infants developing 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 (95% CI) serum 25(OH) D levels in the vitamin D and sunlight group were 16.23 (13.58–19.40) and 11.89 (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.
Conclusion
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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Funding
Funding: Intramural grant from the University College of Medical Sciences, Delhi
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Contributions
Contributions: PG, DS: Study conception, data analysis, manuscript review and final editing; AG, AD: Data collection and analysis, manuscript drafting and writing; RKM: Data analysis, manuscript writing and review; PD: Study conception, manuscript drafting; SVM: Laboratory analysis, manuscript review and editing; All authors have read and approve the final contents of the manuscript.
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Ethics approval: Ethics Committee of University College of Medical Sciences; No. HR/2018/36/105, dated Oct 15, 2018.
Competing interests: None stated.
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Note: Additional material related to this study is available with the online version at https://www.indianpediatrics.net
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Goyal, A., Dabas, A., Shah, D. et al. Sunlight Exposure vs Oral Vitamin D Supplementation for Prevention of Vitamin D Deficiency in Infancy: A Randomized Controlled Trial. Indian Pediatr 59, 852–858 (2022). https://doi.org/10.1007/s13312-022-2642-y
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DOI: https://doi.org/10.1007/s13312-022-2642-y