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Vitamin D Supplement

Vitamin D Supplementation for Premature Birth

N/A

Recruiting

Led By Maria del Mar Romero López, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will compare giving vitamin D to premature babies to usual care. They will look at the effects of vitamin D on the baby's lung, bones, immune system, and brain function.

Who is the study for?

The ViDES Trial is for newborns born at less than 28 weeks gestational age or weighing under 1000 grams. It's not for babies with major birth defects, conditions like cystic fibrosis that affect vitamin D absorption, or those deemed too sick by their neonatologist. Babies over 32 weeks GA can't join regardless of weight.Check my eligibility

What is being tested?

This trial tests if giving extremely premature infants an extra dose of vitamin D (800 IU/day) helps improve their bone health, lung function, immune system, and brain development compared to usual care during the first month after birth.See study design

What are the potential side effects?

Since this trial involves supplementation in very young infants, side effects are monitored closely but may include typical reactions to supplements such as digestive discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

25-hydroxyvitamin D (25[OH]D) level

Alkaline phosphatase level

Calcium level

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual care plus vitamin D supplementationExperimental Treatment2 Interventions

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 (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.

Group II: Usual care plus placeboActive Control2 Interventions

Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,780 Total Patients Enrolled

1 Trials studying Vitamin D Deficiency

50 Patients Enrolled for Vitamin D Deficiency

National Center for Advancing Translational Sciences (NCATS)NIH

321 Previous Clinical Trials

401,569 Total Patients Enrolled

The Gerber FoundationOTHER

41 Previous Clinical Trials

5,816 Total Patients Enrolled

Media Library

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (Vitamin D Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05459298 — N/A

Vitamin D Deficiency Research Study Groups: Usual care plus placebo, Usual care plus vitamin D supplementation

Vitamin D Deficiency Clinical Trial 2023: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth Highlights & Side Effects. Trial Name: NCT05459298 — N/A

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (Vitamin D Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals presently enrolling in this clinical experimentation?

"Affirmative. In accordance with the details on clinicaltrials.gov, this medical study is actively recruiting patients; it was first posted to the website on September 6th 2022 and has been updated most recently on September 8th 2022. The number of participants required for enrolment totals 225 and they must be sourced from 1 location."

Answered by AI

How many individuals are enrolled in this experiment?

"Indeed, clinicaltrial.gov reveals that this study is currently enrolling patients. It was first made available on September 6th 2022 and recently updated on the 8th of the same month. The number of participants required for it to be successful is 225 at a single facility."

Answered by AI

Does this research project include individuals over 30 years old in its recruitment?

"The required age range for participants in this clinical study is between 24 Hours and 96 Hours years old."

Answered by AI

What criteria must an individual satisfy to be eligible for enrollment in this research project?

"This research study is looking for 225 participants with a Vitamin d deficiency, aged 24 to 96 hours. To qualify, infants must have been born at under 28 weeks gestation or weighing less than 1000 grams and informed written consent from the IRB-approved process must be obtained."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ViDES Trial (Vitamin D Extra Supplementation)

Maria del Mar Romero López 2022. "ViDES Trial (Vitamin D Extra Supplementation)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05459298.

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