An interventional study of Oral multivitamin containing vitamin A in Premature, Preterm Infant Health and Vitamin A Deficiency, sponsored by University of Mississippi Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Supportive care
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.
Vitamin A (VA) is an essential micronutrient involved in normal vision, immune function, epithelial integrity, growth, and lung development. Adequate vitamin A status is particularly important during early infancy, a period characterized by rapid growth and organ development. Preterm infants are at increased risk of vitamin A deficiency because they are born before substantial fetal accumulation of vitamin A stores occurs during the third trimester of pregnancy. As a result, many preterm infants begin life with limited vitamin A reserves and depend largely on external sources of nutrition to meet their vitamin A requirements.
Human milk is an important source of vitamin A for infants. However, breast milk vitamin A concentrations vary substantially among lactating mothers and may be influenced by maternal nutritional status and dietary intake. Because preterm infants are especially vulnerable to vitamin A deficiency and its associated complications, including impaired growth, increased susceptibility to infection, and adverse pulmonary outcomes such as bronchopulmonary dysplasia (BPD), interventions that increase vitamin A concentrations in breast milk may provide a practical strategy to improve nutrient delivery to this high-risk population.
Previous studies have evaluated maternal vitamin A supplementation in various populations, but limited information is available regarding the effects of daily standardized-dose vitamin A supplementation in mothers of extremely preterm infants. Furthermore, little is known about the feasibility of implementing such supplementation programs in mothers whose infants require prolonged neonatal intensive care hospitalization.
The primary objective of this pilot study is to evaluate the effect of daily maternal vitamin A supplementation on breast milk vitamin A concentrations during the first four months postpartum in mothers of infants born at less than 29 weeks' gestation. Participants will receive a commercially available oral multivitamin containing 1,300 mcg retinol activity equivalents (RAE) of vitamin A daily for four months after delivery. Breast milk samples will be collected longitudinally to evaluate changes in vitamin A concentrations over time.
A secondary objective is to assess the feasibility of conducting a larger clinical trial of maternal vitamin A supplementation in this population. Feasibility measures will include recruitment rates, participant retention, adherence to supplementation, safety and tolerability, and the practicality of study procedures. Recruitment and retention data will help determine whether mothers of very preterm infants can be successfully enrolled and followed for four months postpartum. Adherence will be assessed through participant self-report and pill counts. Study personnel will evaluate the feasibility of blood collection, breast milk sampling, scheduling of study visits, and completion of data collection procedures within the planned study timeline and available resources.
An additional objective is to determine the relationship between maternal serum retinol concentrations and breast milk vitamin A concentrations during the supplementation period. Maternal serum vitamin A levels and breast milk vitamin A concentrations will be measured at predefined time points to evaluate whether changes in maternal vitamin A status are associated with corresponding changes in breast milk vitamin A content.
This study is designed as a prospective, single-arm interventional pilot study. Approximately 20 lactating mothers of infants born before 29 weeks' gestation will be enrolled. Maternal serum vitamin A concentrations will be measured at baseline, 2 months, and 4 months postpartum. Breast milk vitamin A concentrations will be measured at approximately 2 weeks, 2 months, and 4 months postpartum. Demographic and clinical information will be collected through medical record review and participant surveys. Additional data regarding maternal health, breastfeeding practices, adherence to supplementation, and infant clinical outcomes will be collected throughout the study period.
Participant safety will be monitored throughout the study. The vitamin A dose used in this study is consistent with the Recommended Dietary Allowance (RDA) for lactating women and remains below the established tolerable upper intake level. Maternal serum vitamin A concentrations will be monitored during follow-up visits. Participants will be assessed for symptoms potentially associated with vitamin A excess, including headache, nausea, dizziness, skin changes, and other adverse events. If elevated serum vitamin A levels or symptoms suggestive of hypervitaminosis A occur, supplementation will be discontinued and appropriate clinical evaluation will be performed. Additional laboratory testing, including liver function testing, may be obtained when clinically indicated. Infants will not undergo research blood sampling but will continue to receive routine clinical monitoring as part of standard neonatal intensive care.
Because this is a pilot study, the primary emphasis is on feasibility, safety, adherence, and estimation of effect size rather than formal hypothesis testing. The information obtained will provide important preliminary data regarding the potential effectiveness of maternal vitamin A supplementation in increasing breast milk vitamin A concentrations and will inform the design, implementation, and sample size calculations of future adequately powered clinical trials. The results may contribute to the development of nutritional strategies aimed at improving vitamin A delivery to preterm infants through human milk and ultimately improving health outcomes in this vulnerable population.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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)
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
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
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
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.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 11 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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