RecruitingNot ApplicableNCT07173881

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

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


Sponsor

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Enrollment

20 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

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

Interventions

DIETARY_SUPPLEMENTFortified 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 between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.


Locations(2)

Hospital Interzonal de Agudos General San Martín

La Plata, Buenos Aires, Argentina

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica

La Plata, Buenos Aires, Argentina

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NCT07173881


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