Vitamin D Supplementation for Premature Birth
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the treatment 800 IU/day vitamin D supplementation for premature birth?
Is vitamin D supplementation safe for premature infants?
Vitamin D supplementation in premature infants can be safe if monitored properly, as excessive amounts can lead to potentially toxic levels. In one study, 23% of infants on standard treatment had to stop due to high vitamin D levels, and two infants showed signs of vitamin D toxicity. Monitoring helps maintain safe levels and prevent overdose.12467
How does the drug 800 IU/day vitamin D supplementation differ from other treatments for premature birth?
What is the purpose of this trial?
This trial is testing whether giving extremely premature infants a daily dose of vitamin D can improve their lung, bone, immune system, and brain health. The study focuses on babies born very early or with very low birth weight, who are at higher risk for health issues. Vitamin D supplementation has been studied extensively in preterm and low birth weight infants, showing improvements in growth and vitamin D status but mixed results on other health outcomes.
Research Team
Maria del Mar Romero López, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
The ViDES Trial is for newborns born at less than 28 weeks gestational age or weighing under 1000 grams. It's not for babies with major birth defects, conditions like cystic fibrosis that affect vitamin D absorption, or those deemed too sick by their neonatologist. Babies over 32 weeks GA can't join regardless of weight.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either placebo or vitamin D supplementation at 800 IU/day for the first 28 days after birth
Follow-up
Participants are monitored for safety and effectiveness after treatment, including respiratory support and growth metrics
Long-term follow-up
Assessment of neurodevelopment and growth metrics at 2 years
Treatment Details
Interventions
- 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
- Placebo
- Usual Care
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth is already approved in European Union, United States, Canada for the following indications:
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
- Prevention and treatment of vitamin D deficiency
- Rickets
- Osteomalacia
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
The Gerber Foundation
Collaborator