Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Fortified powder milk
  Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers betwe

Первичные конечные точки

• Breast milk DHA concentration [Срок оценки: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.]
• Mother Zinc concentration [Срок оценки: Mother Zinc concentration will be assessed at one month postpartum]
• mother Vit E concentration [Срок оценки: Mother's serum α-tocopherol concentration will be assessed at one month postpartum]
• Mother Vit A concentration [Срок оценки: Mother's Vit A concentration will be assessed at one month postpartum]
• Mother red blood cell DHA concentration [Срок оценки: Mother's serum DHA concentration will be assessed at one month postpartum]
• Mother hemoglobin concentration [Срок оценки: Mother's hemoglobin concentration will be assessed one month postpartum]
• Breast milk Vitamin A concentration [Срок оценки: Breast milk Vitamin A concentration will be assessed at one month postpartum]
• Breast milk Vitamin E concentration [Срок оценки: Breast milk Vitamin E concentration will be assessed at one month postpartum]
• Breast milk Vitamin D concentration [Срок оценки: Breast milk Vitamin D concentration will be assessed at one month postpartum]
• Breast milk Zinc concentration [Срок оценки: Breast milk Zinc concentration will be assessed at one month postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Women who have had multiple pregnancies and/or women with malabsorption diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Аргентина · 2 центра

• Hospital Interzonal de Agudos General San Martín — La Plata
• Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata

Идентификаторы

NCT: NCT07173881 · UCTH 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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