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

NCT ID: NCT05694689

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2029-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Usual care plus placebo

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Usual Care

Intervention Type: OTHER

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

Usual care plus vitamin D supplementation

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Usual Care

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

Intervention Type: OTHER

Other Intervention Names

Normal saline; Cholecalciferol

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 96 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Maria del Mar Romero López

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Jain, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch

Locations

The University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sunil Jain, MD

Role: CONTACT

skjain@utmb.edu

409-772-2815

Jordan Burdine, PharmD, MBA, BCPPS

Role: CONTACT

jlburdin@utmb.edu

409-772-5070

Facility Contacts

Sunil Jain, MD

Role: primary

skjain@utmb.edu

409-772-2815

Jordan Burdine, PharmD, MBA, BCPPS

Role: backup

jlburdin@utmb.edu

409-772-5070

Other Identifiers

IRB # 22-0217

Identifier Type: -

Identifier Source: org_study_id