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

The University of Texas System (UT)

Status: Enrolling

Conditions: Vitamin D Deficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05694689

IRB # 22-0217

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: 50 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
• An 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

---

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

Treatment:

Dietary Supplement: Placebo

Other: Usual Care

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. 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