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

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

Status: Enrolling

Conditions: Pregnancy

Treatments: Dietary Supplement: Fortified powder milk

Study type: Interventional

Funder types: Other

Identifiers

NCT07173881

UCTH 2025

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Experimental: Super 1.000 Mamá

Experimental group

Description:

Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum.

Treatment:

Dietary Supplement: Fortified powder milk

Sham Comparator: No milk consumption

No Intervention group

Description:

Breastfeeding women who have not consumed SMM until the first month postpartum