Fortified milk for pregnant and breastfeeding women to improve breast milk nutrients
Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population
This will test whether pregnant women who drink Super Mil Mamá, a fortified powdered milk, have higher levels of DHA and key vitamins and minerals in their breast milk at one month after delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri Academic / other |
| Locations | 2 sites (La Plata, Buenos Aires and 1 other locations) |
| Trial ID | NCT07173881 on ClinicalTrials.gov |
What this trial studies
Pregnant women receiving prenatal care in La Plata are offered Super Mil Mamá (SMM), a whole milk powder fortified with multiple vitamins, minerals, and DHA, and their outcomes are compared with women who did not consume the product. The main outcome is the concentration of DHA, vitamins A, E, and D, iron, iodine, zinc, and calcium in human milk at one month postpartum, along with measures of maternal nutritional status. The intervention group is enrolled around 28±1 weeks' gestation and includes women who regularly consume milk; the comparison group includes mothers presenting for their infant's first-month checkup who exclusively breastfeed. Clinical data and milk samples are collected around delivery and at one month postpartum to compare nutrient levels between groups.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old at about 28 weeks' gestation who regularly consume milk, receive care at the participating La Plata clinics, and plan to breastfeed.
Not a fit: Women with multiple pregnancies, malabsorption disorders, those who do not regularly consume milk, or those who do not breastfeed are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the fortified milk could raise important nutrient levels in breast milk and support better infant growth and development in the first month of life.
How similar studies have performed: Previous maternal supplementation studies have shown that adding DHA and certain micronutrients can increase those nutrients in breast milk, but this specific fortified product has not been tested at the population level.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included. * Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included. Exclusion Criteria: * Women who have had multiple pregnancies and/or women with malabsorption diseases.
Where this trial is running
La Plata, Buenos Aires and 1 other locations
- Hospital Interzonal de Agudos General San Martín — La Plata, Buenos Aires, Argentina (Recruiting)
- Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica — La Plata, Buenos Aires, Argentina (Recruiting)
Study contacts
- Study coordinator: Maria F 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.