Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants | NCT07736768

NCT07736768

Overview

NCT ID: NCT07736768
Lead Sponsor: University of Mississippi Medical CenterOTHER
Official Title: The Impact of Maternal Daily Oral High-Dose Vitamin A Supplementation on Vitamin A Concentration in Breast Milk of Mothers of Preterm Infants
Brief Summary: 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.
Conditions

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Mothers aged 18 to 45 years 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 Willing to comply with study procedures, including blood draws and breast milk collection at scheduled time points Able to provide written informed consent

Exclusion Criteria:

Age less than 18 or greater than 45 years Contraindications to breastfeeding or inability to provide breast milk Known liver disease or conditions affecting vitamin A metabolism (e.g., chronic liver disease, known hypervitaminosis A) Baseline elevated vitamin A levels above the normal reference range Multiple gestation pregnancy (if you intend to exclude this-remove if not required) Known substance use disorder that may interfere with adherence or safety Infants with major congenital anomalies or known syndromic conditions Maternal refusal or inability to provide informed consent Planned discontinuation of breastfeeding within 4 months postpartum