Vitamin D Supplementation for Extremely Preterm Infants

NCT01600430 | Completed Phase 2 DMC

• 1 other identifier: UAB Neo 006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Conditions

Vitamin D Deficiency; Preterm Infants; Bronchopulmonary Dysplasia

Keywords

Vitamin D; Newborn; Preterm; Supplementation; Respiratory

Outcome Measures

Primary Outcomes (2)

• Total number of days alive and off respiratory support in the first 28 days

  The total number of days alive and off respiratory support. Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).

  28 days

• Serum vitamin D concentration

  Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)

  Day after birth 28

Secondary Outcomes (13)

• Number of sepsis episodes treated with antibiotics for at least 5 days

  Participants will be followed for the duration of hospital stay, an expected average of 4 months

• Sepsis

  Participants will be followed for the duration of hospital stay, an expected average of 4 months

• Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)

  36 weeks gestational age corrected

• Duration of mechanical ventilation after randomization

  Participants will be followed for the duration of hospital stay, an expected average of 4 months

• Days alive and off mechanical ventilation in the first 28 days after birth

  28 days

Other Outcomes (1)

• Death or Neurodevelopmental Impairment

  Birth to 22-26 months of age

Study Arms (3)

Oral Vitamin D--200 IU/day

ACTIVE COMPARATOR

Cholecalciferol 200 IU given orally once per day

Dietary Supplement: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Identical-appearing treatment that does not contain the test drug given orally four times per day.

Dietary Supplement: Placebo

Oral Vitamin D--800 IU/day

ACTIVE COMPARATOR

Cholecalciferol 800 IU given orally once per day

Dietary Supplement: Cholecalciferol

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days

Also known as: Vitamin D

Oral Vitamin D--200 IU/day

Placebo DIETARY_SUPPLEMENT

Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days

Placebo

Eligibility Criteria

• Age: 1 Minute - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

You may not qualify if:

• Major congenital/chromosomal anomalies
• Moribund infant with low likelihood of survival, in opinion of the clinical team

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Children's Health System, Alabama: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (3)

• Aristizabal N, Holder MP, Durham L, Ashraf AP, Taylor S, Salas AA. Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial. J Acad Nutr Diet. 2023 Jan;123(1):87-94. doi: 10.1016/j.jand.2022.06.012. Epub 2022 Jun 18.

  PMID: 35728797 DERIVED

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

• Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.

  PMID: 27079965 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Bronchopulmonary Dysplasia; Premature Birth

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Namasivayam Ambalavanan, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Ariel A. Salas, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 17, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (1)