Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 4 days
Healthy Volunteers: f
View:
• Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
• Inborn
• Informed written consent in an Institutional Review Board (IRB)-approved manner
Locations
United States
Texas
The University of Texas Medical Branch
RECRUITING
Galveston
Contact Information
Primary
Sunil Jain, MD
skjain@utmb.edu
409-772-2815
Backup
Jordan Burdine, PharmD, MBA, BCPPS
jlburdin@utmb.edu
409-772-5070
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Usual care plus placebo
Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.
Experimental: Usual care plus vitamin D supplementation
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston