ViDES Trial (Vitamin D Extra Supplementation)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Placebo; Other: Usual Care; Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05459298

R03TR005545 (U.S. NIH Grant/Contract)

KL2TR003168 (U.S. NIH Grant/Contract)

HSC-MS-22-0563

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 24 to 96 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• GA >32 weeks regardless of birth weight (BW)
• Any major congenital anomaly
• A known congenital nonbacterial infection
• Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
• Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Usual care plus placebo

Active Comparator group

Description:

Infants will receive placebo (normal saline) in the first 28 days after birth. 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.

Treatment:

Other: Usual Care

Dietary Supplement: Placebo

Usual care plus vitamin D supplementation

Experimental group

Description:

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 (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.

Treatment:

Other: Usual Care

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