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

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
University of Mississippi Medical Center
Study ID
NCT07736768
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral multivitamin containing vitamin A — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jul 30, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Daily Vitamin A Supplementation
    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.

Primary Outcome Measure

Breast Milk Vitamin A (Retinol) Concentration [ Time Frame: 2 weeks, 2 months, and 4 months postpartum (change assessed from 2 weeks baseline to 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Mississippi Medical CenterJacksonMississippi39216-

Find similar trials in Jackson, MS

By research site
University of Mississippi Medical Center· Jackson, MS

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