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Vitamin Supplement

Vitamin D Supplementation for Premature Infants

N/A

Recruiting

Led By Sunil Jain, 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 vitamin D supplementation to usual care in premature babies. Results will be used to measure effects on lung, bone, immune, and brain health.

Who is the study for?

This trial is for very premature infants born at less than 28 weeks or weighing under 1000 grams. It's not for babies with conditions affecting vitamin D absorption, like cystic fibrosis, those too sick where intensive care isn't justified, with congenital infections, over 32 weeks gestation, or with major birth defects.Check my eligibility

What is being tested?

The study tests if giving a high dose of vitamin D (800 IU/day) to extremely premature babies helps their bones, lungs, immune system and brain compared to usual care. Babies are randomly given either the vitamin D supplement or no extra vitamins in their first month.See study design

What are the potential side effects?

Since this trial involves administering vitamin D to preterm infants, potential side effects may include signs of too much calcium like irritability or vomiting but specific risks will be closely monitored by healthcare professionals.

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

+24 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. 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. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.

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

320,947 Total Patients Enrolled

1 Trials studying Vitamin D Deficiency

180 Patients Enrolled for Vitamin D Deficiency

Sunil Jain, MDPrincipal InvestigatorThe University of Texas Medical Branch

2 Previous Clinical Trials

423 Total Patients Enrolled

Media Library

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05694689 — 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: NCT05694689 — N/A

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05694689 — N/A

Frequently Asked Questions

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

Are geriatric patients eligible for inclusion in this trial?

"This trial requires enrollees to be between 24 hours and 96 Hours of age. Additionally, 47 clinical trials are available for minors under 18 years old, while 36 studies can accommodate geriatrics over the age of 65."

Answered by AI

Are there still places available for individuals to participate in this experiment?

"According to the information presented on clinicaltrials.gov, this particular trial is not looking for any more patients as it was last edited on January 20th of 2023. Nonetheless, 85 other studies are actively enrolling participants at present."

Answered by AI

Would I be eligible to take part in this research project?

"The researchers require 50 infants with vitamin d deficiency, aged 24 to 96 hours old. Additionally, the participants must be born earlier than 28 weeks of gestation or less than 1000 grams in birth weight and have provided informed consent adhering to IRB protocol."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Maria del Mar Romero López 2023. "Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694689.

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