Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age

Launched by INDONESIA UNIVERSITY · Nov 3, 2024

Keywords

ClinConnect Summary

This Indonesian study is testing whether giving very preterm babies (born at 28–34 weeks) a higher daily dose of vitamin D by mouth (800 IU) for 28 days helps raise their vitamin D blood levels more than the standard 400 IU daily dose. Babies are randomly assigned to one of the two dose groups, and the study is designed so the families don’t know which dose their child receives. About 54 infants at two Jakarta hospitals (Cipto Mangunkusumo Hospital and RSUD Koja) are planned to enroll. The main question is whether the higher dose leads to a better vitamin D level at the end of 4 weeks.

Eligible babies are those born between 28 and 34 weeks who can tolerate feeding (more than 30 mL per kg of body weight). Exclusions include major birth defects, intestinal blockages, kidney problems present at birth, and a condition called cholestasis. Participants will have a vitamin D blood test before starting and another after 28 days to measure the level of vitamin D in their blood. The study aims to learn if the 800 IU dose is more effective than 400 IU in achieving sufficient vitamin D, and results will be analyzed after the 28-day period. The trial began in 2024 and is expected to finish in early 2025, led by Dr. Rosalina D. Roeslani from Indonesia University.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • neonates with gestational age 28-34 weeks
• • tolerated enteral feedings more than 30ml/kg
• Exclusion Criteria:
• • infants with major congenital anomaly
• • infants with gastrointestinal obstruction
• • infants with congenital renal failure
• • infants with cholestassis