NCT06319079 Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
| NCT ID | NCT06319079 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri |
| Condition | Lactating Mothers |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-06-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06319079 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Lactating Mothers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06319079 currently recruiting?
Yes, NCT06319079 is actively recruiting participants. Contact the research team at mfandreoli@gmail.com for enrollment information.
Where is the NCT06319079 trial being conducted?
This trial is being conducted at La Plata, Argentina.
Who is sponsoring the NCT06319079 clinical trial?
NCT06319079 is sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. The trial plans to enroll 120 participants.