Clinical trial NCT06319079: Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lactating Mothers
Infants
Keywords: human milk
vulnerable population
micronutrients
esencial fatty acids
nutritional supplements
Lead sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: breast milk DHA concentration
timeFrame: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Vitamin A concentration
timeFrame: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Vitamin E concentration
timeFrame: breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Vitamin D concentration
timeFrame: breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Zinc concentration
timeFrame: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Calcium concentration
timeFrame: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Iron concentration
timeFrame: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: breast milk Iodine concentration
timeFrame: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary outcomes:
measure: mother red blood cell DHA concentration
timeFrame: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother Vit A concentration
timeFrame: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother Vit E concentration
timeFrame: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother Vit D concentration
timeFrame: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother Zinc concentration
timeFrame: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother hemoglobin concentration
timeFrame: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: mother serum ferritin concentration
timeFrame: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: child hemoglobin concentration
timeFrame: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: child serum ferritin concentration
timeFrame: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
measure: child red blood cell DHA concentration
timeFrame: child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
state: Buenos Aires
Study officials:
References: