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

NCT07736768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-30

No results posted yet for this study

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

  • Premature
  • Preterm Infant Health
  • Vitamin A Deficiency
  • Human Milk
  • Breastfeeding

Interventions

DIETARY_SUPPLEMENT

Oral multivitamin containing vitamin A

A commercially available oral multivitamin supplement containing 1,300 mcg retinol activity equivalents (RAE) (4,400 IU) of vitamin A will be administered once daily for 4 months to lactating mothers of preterm infants born at less than 29 weeks of gestation. The daily vitamin A dose is consistent with the U.S. Recommended Dietary Allowance (RDA) for lactating women and is below the tolerable upper intake level (UL). The intervention is intended to evaluate the effect of standardized maternal vitamin A supplementation on breast milk vitamin A (retinol) concentrations.

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-30
Completion
2027-11-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736768 on ClinicalTrials.gov