Effect of Vitamin D Supplementation in Healthy Full-Term Infants: A Randomized, Double-Blind, Placebo-Controlled Trial
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Abstract
Objectives: Vitamin D deficiency in infants is a significant global health issue. The aim of this randomized, double-blind, placebo-controlled trial was to assess the effectiveness of vitamin D supplementation in infants at 6 months of age in preventing deficiency or promoting sufficient vitamin D status.
Materials and Methods: Sixty-eight healthy full-term infants were randomly assigned to receive either vitamin D supplementation, 400 international unit (IU)/day (intervention group; n = 34), or placebo (control group; n = 34). Blood samples were collected 48–72 hours after birth to measure serum 25-hydroxyvitamin D (25(OH)D) levels. Supplementation began after blood collection and continued for 6 months. The serum 25(OH)D levels of the two groups were then compared.
Results: After six months, vitamin D supplementation significantly increased mean serum 25(OH)D levels by 7.07 nanograms per milliliter compared to placebo (95% confidence interval (CI): 1.30–12.83; p = 0.016). Among breastfed infants, supplementation with vitamin D 400 IU/day resulted in significantly improved vitamin D status. Notably, 100% of infants in the intervention group achieved vitamin D sufficiency, compared to 77.8% in the control group (p = 0.046). Furthermore, supplemented breastfed infants exhibited significantly higher mean serum 25(OH)D levels at six months (p = 0.019) and a greater increase from baseline (p = 0.010) relative to the control group. In contrast, these effects of supplementation were not observed among formula-fed or mixed-fed infants.
Conclusion: This study highlights the high prevalence of vitamin D insufficiency and deficiency among healthy Thai neonates. Daily supplementation with 400 IU of vitamin D from birth to age 6 months among breastfed infants significantly improved the prevalence of vitamin D sufficiency and elevated serum vitamin D levels by age 6 months without any adverse effects.
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