Vitamin A Supplementation for Breast Milk in Preterm Infants

(VITAL Trial)

MA
LM
Overseen ByLacy Malloch, Project manager
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Mississippi Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs. This study will evaluate whether daily maternal vitamin A supplementation increases vitamin A concentrations in the breast milk of mothers who deliver infants before 29 weeks of gestation.

Participants will receive a commercially available oral multivitamin supplement containing 1,300 mcg retinol activity equivalents (RAE) of vitamin A daily for four months after delivery. Breast milk samples will be collected at 2 weeks, 2 months, and 4 months postpartum to measure vitamin A concentrations. The study will assess whether maternal supplementation is a feasible approach for increasing breast milk vitamin A concentrations in mothers of preterm infants.

Are You a Good Fit for This Trial?

This trial is for mothers who have given birth to preterm infants (before 29 weeks of pregnancy) and are breastfeeding. The study aims to see if taking vitamin A supplements can help increase the amount of vitamin A in their breast milk.

Inclusion Criteria

Delivered an infant born at less than 29 weeks' gestation
Intending to provide breast milk for at least 4 months postpartum
Willing and able to swallow oral tablets
See 3 more

Exclusion Criteria

I am younger than 18 or older than 45 years old.
I have liver disease or problems processing vitamin A.
Baseline elevated vitamin A levels above the normal reference range
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What Are the Treatments Tested in This Trial?

Interventions

  • Oral multivitamin containing vitamin A

Trial Overview

Mothers will take a daily oral multivitamin containing vitamin A for four months after delivery. Researchers will measure how much vitamin A is present in their breast milk at different times during this period.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Daily Vitamin A SupplementationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials
185
Recruited
200,000+