Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition and Nutritional Status of Iron and DHA in Infant Red Blood Cells.. Study in a Vulnerable Population.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- breast milk Vitamin E concentration
研究概览
简要总结
Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients and this will have consequences on the growth and development of the child. In 2021 at IDIP, a specific milk product for pregnant and lactating women Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals and DHA ) has been designed and developed as part of a key strategy to incorporate in public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level.
The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.
Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.
To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.
To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.
To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.
To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The powder milk containers (both SMM and commercial milk) will be packaged by Addvance SA (in the Province of Santa Fe), each of the products will have a label that differentiates them but only the company Addvance SA will know that information. In this project, neither the participating mothers, researchers, and technical staff assigned to the project nor the professional who performs the data analysis knows what product each participant will receive.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.
排除标准
- •Women who have had multiple pregnancies, who receive vitamin or mineral supplements that interfere with the results of the study, and/or women with malabsorption diseases.
研究组 & 干预措施
Leche comercial
Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk.
干预措施: Powder milk (Other)
Super 1.000 Mamá
Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population.
干预措施: Fortified powder milk (Dietary Supplement)
结局指标
主要结局
breast milk Vitamin E concentration
时间窗: breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
breast milk Vitamin A concentration
时间窗: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
breast milk DHA concentration
时间窗: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
breast milk Iron concentration
时间窗: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Calcium concentration in breast milk expressed in mg/dl
breast milk Zinc concentration
时间窗: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Zinc concentration in breast milk expressed in mg/dl
breast milk Vitamin D concentration
时间窗: breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
25-hidroxi vitamin D concentration in breast milk expressed in ng/ml
breast milk Calcium concentration
时间窗: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Calcium concentration in breast milk expressed in mg/dl
breast milk Iodine concentration
时间窗: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Iodine concentration in breast milk expressed in mg/dl
次要结局
- mother Vit E concentration(mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- child serum ferritin concentration(child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother Vit D concentration(mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother Zinc concentration(mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother serum ferritin concentration(mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother red blood cell DHA concentration(mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother Vit A concentration(mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- mother hemoglobin concentration(mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- child hemoglobin concentration(child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))
- child red blood cell DHA concentration(child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum))