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Objective <p>To determine the efficacy and safety of daily supplementation of 800&#xa0;IU versus 400&#xa0;IU vitamin D<sub>3</sub> in reducing the incidence of vitamin D insufficiency (VDI) (serum 25-OH-D &lt; 20&#xa0;ng/mL) in exclusively breastfed term small-for-gestational-age (SGA) infants at 14&#xa0;weeks of age.</p> Methods <p>An open-label randomized controlled trial including exclusively breastfed term SGA infants was conducted in a tertiary care hospital. Eligible infants were randomized within 24&#xa0;h of life to receive either 800&#xa0;IU or 400&#xa0;IU daily oral vitamin D<sub>3</sub> supplementation until 14&#xa0;weeks of age. Primary outcome was proportion of infants with VDI at 14&#xa0;weeks, while secondary outcomes included vitamin D deficiency (VDD) (serum 25-OH-D &lt; 12&#xa0;ng/mL), severe VDD (serum 25-OH-D &lt; 5&#xa0;ng/mL), clinical rickets, and vitamin D toxicity (VDT) (serum 25-OH-D &gt; 100&#xa0;ng/mL).</p> Results <p>Among 60 enrolled infants, the distribution of baseline variables was similar in both groups. The proportion of infants with VDI at 14&#xa0;weeks was significantly less in 800&#xa0;IU (30%) versus 400&#xa0;IU (63.3%) group (RR = 0.47, 95% CI 0.18, 0.73; <i>P</i> = 0.016). In the 800&#xa0;IU group, there was a trend towards reduction in the proportion of infants with VDD, and no infant with severe VDD. Clinical rickets was seen in 3 infants (1 in 800&#xa0;IU and 2 in 400&#xa0;IU), with all having VDD. None of the infants had VDT.</p> Conclusion <p>Daily oral supplementation of 800&#xa0;IU vitamin D<sub>3</sub> in exclusively breastfed term SGA infants significantly reduced the proportion of infants with vitamin D insufficiency without any toxicity.</p> <p><i>Trial registry</i> CTRI/2023/08/071999</p>

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Efficacy of 800 IU Versus 400 IU Daily Oral Vitamin D3 Supplementation for Vitamin D Insufficiency Among Term Small-for-Gestational Age Breastfed Infants: An Open Label Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年4月29日

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  • Sudarshan Jayasimha,
  • Bhawna Dubey

摘要

Objective

To determine the efficacy and safety of daily supplementation of 800 IU versus 400 IU vitamin D3 in reducing the incidence of vitamin D insufficiency (VDI) (serum 25-OH-D < 20 ng/mL) in exclusively breastfed term small-for-gestational-age (SGA) infants at 14 weeks of age.

Methods

An open-label randomized controlled trial including exclusively breastfed term SGA infants was conducted in a tertiary care hospital. Eligible infants were randomized within 24 h of life to receive either 800 IU or 400 IU daily oral vitamin D3 supplementation until 14 weeks of age. Primary outcome was proportion of infants with VDI at 14 weeks, while secondary outcomes included vitamin D deficiency (VDD) (serum 25-OH-D < 12 ng/mL), severe VDD (serum 25-OH-D < 5 ng/mL), clinical rickets, and vitamin D toxicity (VDT) (serum 25-OH-D > 100 ng/mL).

Results

Among 60 enrolled infants, the distribution of baseline variables was similar in both groups. The proportion of infants with VDI at 14 weeks was significantly less in 800 IU (30%) versus 400 IU (63.3%) group (RR = 0.47, 95% CI 0.18, 0.73; P = 0.016). In the 800 IU group, there was a trend towards reduction in the proportion of infants with VDD, and no infant with severe VDD. Clinical rickets was seen in 3 infants (1 in 800 IU and 2 in 400 IU), with all having VDD. None of the infants had VDT.

Conclusion

Daily oral supplementation of 800 IU vitamin D3 in exclusively breastfed term SGA infants significantly reduced the proportion of infants with vitamin D insufficiency without any toxicity.

Trial registry CTRI/2023/08/071999