Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

January 1, 2026

Study Completion Date

June 1, 2029

Conditions
Vitamin D Deficiency
Interventions
DIETARY_SUPPLEMENT

Placebo

Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.

DIETARY_SUPPLEMENT

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.

OTHER

Usual Care

Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices

Trial Locations (1)

77555

RECRUITING

The University of Texas Medical Branch, Galveston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER