Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Evaluating a milk product for lactating women and its effects 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.

Run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · NCT06319079 · Data updated 2026-11-12

This study is testing whether a special milk product can improve the nutrition in breast milk for women who are breastfeeding.

More Healthy Infants trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment120 (estimated)
SponsorInstituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Academic / other
Locations1 site (La Plata, Buenos Aires)
StatusRecruiting
StartedJune 1, 2024
Main results expectedMarch 1, 2026
Study endsJuly 1, 2027
Registry record updatedSeptember 27, 2024
Trial IDNCT06319079 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
    La Plata, Buenos Aires, Argentina
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.