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.

Overview

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.

Interventions

• Dietary supplement Fortified powder milk
  Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers betwe
• Other Powder milk
  Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Primary outcome measures

• breast milk DHA concentration [Time frame: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin A concentration [Time frame: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin E concentration [Time frame: breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Vitamin D concentration [Time frame: breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Zinc concentration [Time frame: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Calcium concentration [Time frame: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Iron concentration [Time frame: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• breast milk Iodine concentration [Time frame: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]

Secondary outcome measures (10)

• mother red blood cell DHA concentration [Time frame: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Vit A concentration [Time frame: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Vit E concentration [Time frame: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Vit D concentration [Time frame: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother Zinc concentration [Time frame: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother hemoglobin concentration [Time frame: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• mother serum ferritin concentration [Time frame: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• child hemoglobin concentration [Time frame: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• child serum ferritin concentration [Time frame: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)]
• child red blood cell DHA concentration [Time frame: 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Argentina · 1 center

• Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata

Identifiers

NCT: NCT06319079 · UCTH 2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗