Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition

Официальное название

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.

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 ) 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.

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
• Другое Powder milk
  Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Первичные конечные точки

• breast milk DHA concentration [Срок оценки: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin A concentration [Срок оценки: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin E concentration [Срок оценки: breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin D concentration [Срок оценки: breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Zinc concentration [Срок оценки: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Calcium concentration [Срок оценки: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Iron concentration [Срок оценки: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Iodine concentration [Срок оценки: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]

Вторичные конечные точки (10)

• mother red blood cell DHA concentration [Срок оценки: 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 [Срок оценки: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Vit E concentration [Срок оценки: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Vit D concentration [Срок оценки: 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 [Срок оценки: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother hemoglobin concentration [Срок оценки: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother serum ferritin concentration [Срок оценки: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• child hemoglobin concentration [Срок оценки: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• child serum ferritin concentration [Срок оценки: child serum ferritin 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.

Критерии исключения

• 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.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Аргентина · 1 центр

• Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata

Идентификаторы

NCT: NCT06319079 · UCTH 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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