Health TrialsbyHealthPanel

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

ConditionsPrematurePreterm Infant HealthVitamin A DeficiencyHuman MilkBreastfeeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Mississippi Medical Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Daily Vitamin A SupplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Breast Milk Vitamin A (Retinol) Concentration

Change in breast milk vitamin A (retinol) concentration following maternal daily oral vitamin A supplementation. Breast milk retinol levels will be quantified using standardized fluorometric assay methods.

Time frame
2 weeks, 2 months, and 4 months postpartum (change assessed from 2 weeks baseline to 4 months)

Secondary outcomes

1

Recruitment and Retention Rate

Feasibility of enrolling and retaining mothers of extremely preterm infants in a 4-month longitudinal supplementation study. Recruitment rate will be defined as the proportion of eligible mothers who consent to participate. Retention will be defined as the proportion of enrolled participants completing follow-up through 4 months postpartum.

Time frame
From enrollment through 4 months postpartum
2

Adherence to Vitamin A Supplementatio

Participant adherence to daily oral vitamin A supplementation will be assessed using pill counts and self-reported intake logs. Adherence will be expressed as the percentage of prescribed doses taken over the study period.

Time frame
Throughout 4 months of supplementation
3

Feasibility of Study Procedures and Visit Completion

Assessment of practicality of study procedures including scheduling of visits, blood draws, breast milk collection, and data collection using REDCap. Feasibility will be evaluated based on completion rates of study visits and successful sample collection at each time point.

Time frame
Throughout 4 months
4

Maternal serum retinol concentration

Maternal Serum Retinol Concentration

Time frame
Baseline, 2 months, and 4 months Maternal serum retinol concentration (mcg/dL) measured using standardized laboratory methods.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Mississippi Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: