Evaluating a milk product for lactating women and its effects 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.
This study is testing whether a special milk product can improve the nutrition in breast milk for women who are breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri Academic / other |
| Locations | 1 site (La Plata, Buenos Aires) |
| Trial ID | NCT06319079 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of a specially formulated milk product, Super Mil Mamá, on the nutritional composition of human milk produced by lactating women. The study will involve a randomized, triple-blind, controlled design to compare the levels of essential nutrients such as DHA, vitamins, and minerals in the milk of participants who consume the product versus those who do not. The target population includes vulnerable women who regularly breastfeed and may have dietary deficiencies. The findings could inform public health policies regarding maternal nutrition during the critical first 1000 days of life.
Who should consider this trial
Good fit: Ideal candidates for this study are breastfeeding women attending their child's first check-up within the first month of life who consume milk regularly.
Not a fit: Women with multiple pregnancies, those taking conflicting vitamin or mineral supplements, or those with malabsorption diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the nutritional quality of human milk, benefiting both lactating mothers and their infants.
How similar studies have performed: While the specific product has not been evaluated at the population level, similar interventions targeting maternal nutrition have shown promise in improving infant health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Plata, Buenos Aires
- Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata, Buenos Aires, Argentina (Recruiting)
Study contacts
- Study coordinator: Maria Florencia Andreoli, PhD
- Email: mfandreoli@gmail.com
- Phone: 542214177324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.