ViDES Study

Small premature babies don’t get much vitamin D before birth and often are born with low vitamin D in their blood. We don’t know how much vitamin D small premature babies need to grow and develop well after birth. Giving extra vitamin D with their feedings may increase the vitamin D in their blood and prevent infection and help the lungs, bones and the brain to develop well. This study is being done to learn if giving extra vitamin D with feedings will improve the vitamin D levels in the blood and reduce breathing problems, infections, slow development, and improve bone growth.

Babies will be given either the usual amount of vitamin D in his/her feedings and IV fluids or extra vitamin D through the feeding tube shortly before feedings for the first 28 days after birth. Baby’s other care won’t be affected. We will measure blood levels of vitamin D and monitor growth, lung function, infections, and neurodevelopmental assessment at follow-up at 22-26 months postnatal age.

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Purpose & Aim

Population of the study: Extremely preterm infants <28 weeks’ gestation or <1000 grams birthweight born at Children’s Memorial Hermann Hospital or University of Texas Medical Branch Hospital (Galveston)
Intervention: Extra vitamin D with feeds (800 IU/day)
Control (Usual care in our hospital):  Vitamin D when the infant receives full feeds (400 IU/day)
Outcome: Vitamin D levels, growth, lung function, neurodevelopmental assessment

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Trial Information

Recruitment Target: 180
Sponsor: NIH Center for Clinical and Translational Sciences (NCATS)
Funder: NIH NCATS KL2 Career Development Award (5KL2TR003168), July 2022 – July 2024 and The Gerber Foundation, July 2023 – June 2026
Duration of Study: September 2022 – June 2025

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Study Principal Investigator

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Links

Protocol
ClinicalTrials.gov