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Vitamin D Supplementation for Extremely Preterm Infants

NCT01600430 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-02-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

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

DIETARY_SUPPLEMENT

Cholecalciferol

800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Children's Health System, Alabama

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Namasivayam Ambalavanan, MD · University of Alabama at Birmingham

  • Ariel A. Salas, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600430 on ClinicalTrials.gov