NCT06319079

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lactating Mothers
• Infants

Interventions

Type	Name	Description
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 between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.
OTHER	Powder milk	Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-03-01
• Completion: 2027-07-01
• First posted: 2024-03-19
• Last updated: 2024-09-27

Locations

1 site across 1 country: Argentina