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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri Academic / other |
| Locations | 1 site (La Plata, Buenos Aires) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | March 1, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | September 27, 2024 |
| Trial ID | NCT06319079 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
- Study coordinator: Maria Florencia Andreoli, PhD
- Email: mfandreoli@gmail.com
- Phone: 542214177324
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Higher caffeine dose to improve breathing in extremely premature babies
This trial tests whether giving caffeine citrate at 10 mg/kg helps oxygenation in extremely premature infants compared with the standard 5 mg/kg dose.
-
Impact of Labor Pain Relief on Child Development
This study looks at whether using epidurals for pain relief during labor affects how children develop by the time they are two years old.
-
Probiotic supplement in healthy infants to study gut microbiota and immune function
Giving a probiotic to healthy infants from birth up to 6 months old to see how it affects their gut bacteria and immune health.
-
Growth, tolerance, and gut markers in healthy infants given dietary supplements
This study tests whether giving probiotic supplements to healthy newborns helps with weight gain and gut health compared with a placebo.
-
Preventing excessive crying and colic in newborns with a probiotic supplement of two L. reuteri strains
This will try giving healthy newborns a dietary supplement containing two L. reuteri probiotic strains plus vitamin D during their first three months to see if it reduces excessive crying and infantile colic compared with a placebo.
-
Dietary supplement in healthy infants
A double-blind, placebo-controlled study is testing whether a dietary supplement given to healthy term infants can change their gut microbiome compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.