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

Infants Clinical Trial

Official title:
Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition and Nutritional Status of Iron and DHA in Infant Red Blood Cells.. Study in a Vulnerable Population.

Clinical Trial 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 ) 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06319079
Study type Interventional
Source Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Contact Maria Florencia Andreoli, PhD
Phone +542214177324
Email mfandreoli@gmail.com
Status Not yet recruiting
Phase N/A
Start date March 2024
Completion date July 2027
View Details
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