ViDES Trial (Vitamin D Extra Supplementation)

NAActive, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 6, 2022

Primary Completion Date

August 12, 2025

Study Completion Date

December 1, 2027

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 (started when infants receive full feedings of about 120-160 mL/kg/day). 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

Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Trial Locations (1)

77006

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

The Gerber Foundation

OTHER

lead

The University of Texas Health Science Center, Houston

OTHER