Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07173881

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

Led by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Updated on 2025-09-15

20

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

I

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

Lead Sponsor

H

Hospital Interzonal de Agudos General San Martín

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women over 18 years old in gestational weeks 28 ± 1 who receive prenatal care at the Maternal Nutrition Clinic and regularly consume milk
  • Women over 18 years old attending their child's first checkup before the child is one month old and exclusively breastfeeding
Not Eligible

You will not qualify if you...

  • Women who have had multiple pregnancies
  • Women with malabsorption diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Interzonal de Agudos General San Martín

La Plata, Buenos Aires, Argentina, 1900

Actively Recruiting

2

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

La Plata, Buenos Aires, Argentina, 1900

Actively Recruiting

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Research Team

M

Maria F Andreoli, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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