ViDES Trial (Vitamin D Extra Supplementation)

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).

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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• The Gerber Foundation

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Maria del Mar Romero López, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

24 Hours

Max Age

96 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-06

Primary Completion

2025-08-12

Completion

2027-12-01

Countries

• United States

Study Locations