Vitamin A Supplementation for Breast Milk in Preterm Infants
(VITAL Trial)
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
Exclusion Criteria
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
Lactating mothers of preterm infants born at less than 29 weeks of gestation will receive a commercially available oral multivitamin containing 1,300 mcg retinol activity equivalents (RAE) (4,400 IU) of vitamin A once daily for 4 months. Breast milk vitamin A (retinol) concentrations will be measured at baseline and at 2 weeks, 2 months, and 4 months postpartum to evaluate the effect of standardized vitamin A supplementation on breast milk vitamin A levels.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Mississippi Medical Center
Lead Sponsor
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