Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental 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
- 20
- 试验地点
- 4
- 主要终点
- mother Vit D 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 ) was designed and developed as part of a key strategy to incorporate into 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 pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.
Specific objectives include:
To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included.
- •Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.
排除标准
- •Women who have had multiple pregnancies and/or women with malabsorption diseases.
研究组 & 干预措施
Experimental: Super 1.000 Mamá
Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum.
干预措施: Fortified powder milk (Dietary Supplement)
Sham Comparator: No milk consumption
Breastfeeding women who have not consumed SMM until the first month postpartum
结局指标
主要结局
mother Vit D concentration
时间窗: mother Vit D concentration will be assessed at one month postpartum
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
Breast milk Iodine concentration
时间窗: Breast milk Iodine concentration will be assessed at one month postpartum
Iodine concentration in breast milk expressed in mg/dl
Mother serum ferritin concentration
时间窗: Mother's serum ferritin concentration will be assessed at one month postpartum
ferritin concentration in mother serum expressed in ng/ml
Mother Vit A concentration
时间窗: Mother's Vit A concentration will be assessed at one month postpartum
Retinol concentration in mother serum expressed in μmol/L
Mother red blood cell DHA concentration
时间窗: Mother's serum DHA concentration will be assessed at one month postpartum
Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Breast milk DHA concentration
时间窗: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.
Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Mother Zinc concentration
时间窗: Mother Zinc concentration will be assessed at one month postpartum
Zinc concentration in mother serum expressed in mg/dl
mother Vit E concentration
时间窗: Mother's serum α-tocopherol concentration will be assessed at one month postpartum
α-tocopherol concentration in mother serum expressed in μmol/L
Mother Vit A concentration
时间窗: Mother's Vit A concentration will be assessed at one month postpartum
Retinol concentration in mother serum expressed in μmol/L
Mother red blood cell DHA concentration
时间窗: Mother's serum DHA concentration will be assessed at one month postpartum
Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Mother hemoglobin concentration
时间窗: Mother's hemoglobin concentration will be assessed one month postpartum
hemoglobin concentration in mother serum expressed in g/dL
Breast milk Vitamin A concentration
时间窗: Breast milk Vitamin A concentration will be assessed at one month postpartum
Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Breast milk Vitamin E concentration
时间窗: Breast milk Vitamin E concentration will be assessed at one month postpartum
α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Breast milk Vitamin D concentration
时间窗: Breast milk Vitamin D concentration will be assessed at one month postpartum
25-hidroxi vitamin D concentration in breast milk expressed in ng/ml
Breast milk Zinc concentration
时间窗: Breast milk Zinc concentration will be assessed at one month postpartum
Zinc concentration in breast milk expressed in mg/dl
Breast milk Calcium concentration
时间窗: Breast milk Calcium concentration will be assessed at one month postpartum
Calcium concentration in breast milk expressed in mg/dl
Breast milk Iron concentration
时间窗: Breast milk Iron concentration will be assessed at one month postpartum
Iron concentration in breast milk expressed in mg/dl
Breast milk Iodine concentration
时间窗: Breast milk Iodine concentration will be assessed at one month postpartum
Iodine concentration in breast milk expressed in mg/dl
Mother serum ferritin concentration
时间窗: Mother's serum ferritin concentration will be assessed at one month postpartum
ferritin concentration in mother serum expressed in ng/ml
mother Vit D concentration
时间窗: mother Vit D concentration will be assessed at one month postpartum
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
次要结局
未报告次要终点