Vitamin D for Premature Infants

Recruiting in Palo Alto (17 mi)

Overseen byAmy h, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth. Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).

Eligibility Criteria

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.

Inclusion 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.

+11 more

Exclusion Criteria

I have major birth defects, severe NEC (a serious gut condition) or can't tolerate feeding well.

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.

+1 more

Participant Groups

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.

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.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vitamin D for: