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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Vitamin D Deficiency+1 More
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth - DietarySupplement
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Vitamin D Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vitamin D Deficiency

Study Objectives

0 Primary · 21 Secondary · Reporting Duration: 2 years

Week 36
Alkaline phosphatase level
Calcium level
Phosphorus level
2 years
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Neurodevelopment as assessed by the Bayley-IV Scales of Infant and Toddler Development
Number of participants with neurodevelopmental impairment (NDI)
Number of participants with wheezing
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Month 26
Number of participants who are still on respiratory support
36 weeks after birth
25-hydroxyvitamin D (25[OH]D) level
36 weeks postmenstrual age
Number of participants who die or have a morbidity
Number of participants with pulmonary hypertension
Week 36
Type of respiratory support required at 36 weeks postmenstrual age
Week 36
Number of participants who receive steroid treatment to decrease respiratory support
Number of participants with any fractures
Week 60
Number of participants with hospital-acquired sepsis
Week 60
Length of Hospital stay
Number of days of mechanical ventilation
Number of days of positive pressure support
Number of days of supplemental oxygen

Trial Safety

Safety Progress

1 of 3

Other trials for Vitamin D Deficiency

Trial Design

2 Treatment Groups

Usual care plus placebo
1 of 2
Usual care plus vitamin D supplementation
1 of 2
Active Control
Experimental Treatment

225 Total Participants · 2 Treatment Groups

Primary Treatment: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth · Has Placebo Group · N/A

Usual care plus vitamin D supplementationExperimental Group · 2 Interventions: Usual Care, 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth · Intervention Types: Other, DietarySupplement
Usual care plus placeboActiveComparator Group · 2 Interventions: Placebo, Usual Care · Intervention Types: DietarySupplement, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2008First Recorded Clinical Trial
1 TrialsResearching Vitamin D Deficiency
190 CompletedClinical Trials

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
785 Previous Clinical Trials
245,318 Total Patients Enrolled
Maria del Mar Romero López, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a baby born at less than 28 weeks gestation or less than 1000 grams birth weight.
You have provided informed written consent to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.