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

NCT07736768 | Not Yet Recruiting DMC

• 1 other identifier: UMMC-IRB-2025-51
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitamin a supplementation; human milk retinol; breast milk vitamin A; infant nutrition; milk micronutrients; lactation; feasibility study

Outcome Measures

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.

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

Secondary Outcomes (4)

• Recruitment and Retention Rate

  From enrollment through 4 months postpartum

• Adherence to Vitamin A Supplementatio

  Throughout 4 months of supplementation

• Feasibility of Study Procedures and Visit Completion

  Throughout 4 months

• Maternal serum retinol concentration

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

Study Arms (1)

Daily Vitamin A Supplementation

EXPERIMENTAL

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

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.

Daily Vitamin A Supplementation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female. only lactating mothers can enroll.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (6)

• Dimenstein R, Lourenco RM, Ribeiro KD. [Impact on colostrum retinol levels of immediate postpartum supplementation with retinyl palmitate]. Rev Panam Salud Publica. 2007 Jul;22(1):51-4. doi: 10.1590/s1020-49892007000600007. Portuguese.

  PMID: 17931488 RESULT

• Ding Y, Hu P, Yang Y, Xu F, Li F, Lu X, Xie Z, Wang Z. Impact of Maternal Daily Oral Low-Dose Vitamin A Supplementation on the Mother-Infant Pair: A Randomised Placebo-Controlled Trial in China. Nutrients. 2021 Jul 10;13(7):2370. doi: 10.3390/nu13072370.

  PMID: 34371880 RESULT

• Lima MS, da Silva Ribeiro KD, Pires JF, Bezerra DF, Bellot PE, de Oliveira Weigert LP, Dimenstein R. Breast milk retinol concentration in mothers of preterm newborns. Early Hum Dev. 2017 Mar-Apr;106-107:41-45. doi: 10.1016/j.earlhumdev.2017.01.006. Epub 2017 Feb 8.

  PMID: 28189000 RESULT

• Rakshasbhuvankar A, Patole S, Simmer K, Pillow JJ. Enteral vitamin A for reducing severity of bronchopulmonary dysplasia in extremely preterm infants: a randomised controlled trial. BMC Pediatr. 2017 Dec 16;17(1):204. doi: 10.1186/s12887-017-0958-x.

  PMID: 29246130 RESULT

• Giridhar S, Kumar J, Attri SV, Dutta S, Kumar P. Intramuscular Followed by Oral Vitamin A Supplementation in Neonates with Birth Weight from 750 to 1250 g: A Randomized Controlled Trial. Indian J Clin Biochem. 2020 Apr;35(2):197-204. doi: 10.1007/s12291-018-0807-1. Epub 2019 Jan 3.

  PMID: 32226251 RESULT

• Huang L, Zhu D, Pang G. The effects of early vitamin A supplementation on the prevention and treatment of bronchopulmonary dysplasia in premature infants: a systematic review and meta-analysis. Transl Pediatr. 2021 Dec;10(12):3218-3229. doi: 10.21037/tp-21-496.

  PMID: 35070836 RESULT

Related Links

• Drugs and Lactation Database (LactMed®) \[Internet\]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Vitamin A. \[Updated 2024 Sep 15\].
• Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial

MeSH Terms

Conditions

Premature Birth; Vitamin A Deficiency; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Central Study Contacts

Maher Ajour, MD

CONTACT

7073104764; majour@umc.edu

Lacy Malloch, Project manager

CONTACT

601-815-4517; lmalloch@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This is a prospective single-arm interventional pilot study in which all enrolled participants receive daily oral vitamin A supplementation. Outcomes are assessed longitudinally within participants over time. There is no control or placebo group. Repeated measures of breast milk vitamin A concentrations and maternal serum retinol levels are collected at predefined postpartum time points to evaluate changes over the course of supplementation and to support feasibility and effect size estimation for future controlled studies.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)