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

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

Status: Enrolling

Conditions: Lactating Mothers; Infants

Treatments: Other: Powder milk; Dietary Supplement: Fortified powder milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06319079

UCTH 2024

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 ) 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Super 1.000 Mamá

Experimental group

Description:

Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population.

Treatment:

Dietary Supplement: Fortified powder milk

Leche comercial

Sham Comparator group

Description:

Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk.

Treatment:

Other: Powder milk