The Impact of Maternal Daily Oral High-Dose Vitamin A Supplementation on Vitamin A Concentration in Breast Milk of Mothers of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Breast Milk Vitamin A (Retinol) Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Breast Milk Vitamin A (Retinol) Concentration
时间窗: 2 weeks, 2 months, and 4 months postpartum (change assessed from 2 weeks baseline to 4 months)
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.
次要结局
- 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.)
研究者
Maher Ajour
Assistant professor
University of Mississippi Medical Center