Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants (NCT07736768) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
United States20 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Breast Milk Vitamin A (Retinol) Concentration
Timeframe: 2 weeks, 2 months, and 4 months postpartum (change assessed from 2 weeks baseline to 4 months)