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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 up to 5 years

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110

12%

Back pain

Arthralgia

Fall

Humerus fracture

Hip fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

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

~3670

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