Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fortified powder milk.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Dietary supplement 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
Primary outcome measures
- Breast milk DHA concentration [Time frame: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.]
- Mother Zinc concentration [Time frame: Mother Zinc concentration will be assessed at one month postpartum]
- mother Vit E concentration [Time frame: Mother's serum α-tocopherol concentration will be assessed at one month postpartum]
- Mother Vit A concentration [Time frame: Mother's Vit A concentration will be assessed at one month postpartum]
- Mother red blood cell DHA concentration [Time frame: Mother's serum DHA concentration will be assessed at one month postpartum]
- Mother hemoglobin concentration [Time frame: Mother's hemoglobin concentration will be assessed one month postpartum]
- Breast milk Vitamin A concentration [Time frame: Breast milk Vitamin A concentration will be assessed at one month postpartum]
- Breast milk Vitamin E concentration [Time frame: Breast milk Vitamin E concentration will be assessed at one month postpartum]
- Breast milk Vitamin D concentration [Time frame: Breast milk Vitamin D concentration will be assessed at one month postpartum]
- Breast milk Zinc concentration [Time frame: Breast milk Zinc concentration will be assessed at one month postpartum]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Women who have had multiple pregnancies and/or women with malabsorption diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Argentina · 2 centers
- Hospital Interzonal de Agudos General San Martín — La Plata
- Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata
Identifiers
NCT: NCT07173881 · UCTH 2025