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Vitamin
Vitamin D for Premature Infants
N/A
Waitlist Available
Led By Amy h, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up last 7 days of hospitalization and at 52 weeks pma
Awards & highlights
Study Summary
This trial is testing whether a vitamin D supplement in a transitional formula given to premature babies will lead to higher serum levels of vitamin D at 52 weeks PMA, and whether any infants will have a serum vitamin D level below 20 ng/mL.
Who is the study for?
This trial is for preterm infants born between 28 and 34 weeks gestation, weighing 1000-2250g, who are now 34 to almost 39 weeks post-menstrual age. They should be transitioning to formula feeding and not on mechanical ventilation or diuretics. Infants with severe lung disease requiring daily diuretics, major birth defects, serious intestinal issues, or needing high-calorie formulas can't join.Check my eligibility
What is being tested?
The study tests if adding vitamin D to a transitional formula improves vitamin D levels in preterm infants without causing levels to drop below a certain threshold when checked around their first birthday after expected delivery (52 weeks PMA). Half will receive the supplement; the other half will get a placebo.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, common concerns with vitamin supplementation might include digestive discomfort or allergic reactions. Close monitoring ensures any potential side effects are identified early.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ last 7 days of hospitalization and at 52 weeks post-menstrual age (pma)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last 7 days of hospitalization and at 52 weeks post-menstrual age (pma)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age
Secondary outcome measures
Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age
Side effects data
From 2016 Phase 4 trial • 1366 Patients • NCT0170911012%
Back pain
7%
Arthralgia
3%
Fall
1%
Hip fracture
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational NutritionExperimental Treatment1 Intervention
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Investigational Nutrition group will receive vitamin D drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
Group II: Routine NutritionPlacebo Group1 Intervention
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Routine Nutrition group will receive placebo drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470
Find a Location
Who is running the clinical trial?
Mead Johnson NutritionIndustry Sponsor
79 Previous Clinical Trials
16,329 Total Patients Enrolled
The Children's Nutrition Research CenterOTHER
1 Previous Clinical Trials
108 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was born prematurely, between 28 and 34 weeks, weighing 1000-2250g.I am not on a ventilator or taking water pills, but I may use a low flow nasal cannula.I am between 34 and 38 weeks pregnant.I have major birth defects, severe NEC (a serious gut condition) or can't tolerate feeding well.I was born between 28 and 34 weeks of pregnancy and weighed between 1000-2250g.I am pregnant with twins, not with triplets or more.My baby needs daily diuretics and special formula due to BPD after 38 weeks PMA.I am not on a ventilator or taking water pills, but I may use a low flow nasal cannula.I am between 34 and 38 weeks pregnant.I can tolerate a specific high-calorie formula and take in enough of it daily.I can tolerate a specific dietary formula and consume enough of it daily.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Nutrition
- Group 2: Routine Nutrition
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this medical experiment still possible?
"According to the clinicaltrials.gov listing, the application period for this medical trial has been closed since its last edit on October 6th 2022. Even though there is no current requirement for patients, 39 additional studies are actively looking for participants right now."
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