Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk

NCT07173881 | Recruiting

• 1 other identifier: UCTH 2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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 ) was designed and developed as part of a key strategy to incorporate into 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 pregnant women on maternal nutritional status and the composition of human milk at one month postpartum. Specific objectives include: To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not. To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.

Conditions

Pregnancy

Keywords

human milk; vulnerable population; pregnancy; nutritional supplements; esencial fatty acids; micronutrients

Outcome Measures

Primary Outcomes (15)

• Breast milk DHA concentration

  Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample

  Time Frame: breast milk DHA concentration will be assessed at one month postpartum.

• Mother Zinc concentration

  Zinc concentration in mother serum expressed in mg/dl

  Mother Zinc concentration will be assessed at one month postpartum

• mother Vit E concentration

  α-tocopherol concentration in mother serum expressed in μmol/L

  Mother's serum α-tocopherol concentration will be assessed at one month postpartum

• Mother Vit A concentration

  Retinol concentration in mother serum expressed in μmol/L

  Mother's Vit A concentration will be assessed at one month postpartum

• Mother red blood cell DHA concentration

  Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample

  Mother's serum DHA concentration will be assessed at one month postpartum

• Mother hemoglobin concentration

  hemoglobin concentration in mother serum expressed in g/dL

  Mother's hemoglobin concentration will be assessed one month postpartum

• Breast milk Vitamin A concentration

  Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample

  Breast milk Vitamin A concentration will be assessed at one month postpartum

• Breast milk Vitamin E concentration

  α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample

  Breast milk Vitamin E concentration will be assessed at one month postpartum

• Breast milk Vitamin D concentration

  25-hidroxi vitamin D concentration in breast milk expressed in ng/ml

  Breast milk Vitamin D concentration will be assessed at one month postpartum

• Breast milk Zinc concentration

  Zinc concentration in breast milk expressed in mg/dl

  Breast milk Zinc concentration will be assessed at one month postpartum

• Breast milk Calcium concentration

  Calcium concentration in breast milk expressed in mg/dl

  Breast milk Calcium concentration will be assessed at one month postpartum

• Breast milk Iron concentration

  Iron concentration in breast milk expressed in mg/dl

  Breast milk Iron concentration will be assessed at one month postpartum

• Breast milk Iodine concentration

  Iodine concentration in breast milk expressed in mg/dl

  Breast milk Iodine concentration will be assessed at one month postpartum

• Mother serum ferritin concentration

  ferritin concentration in mother serum expressed in ng/ml

  Mother's serum ferritin concentration will be assessed at one month postpartum

• mother Vit D concentration

  25-hidroxi vitamin D concentration in mother serum expressed in ng/ml

  mother Vit D concentration will be assessed at one month postpartum

Study Arms (2)

Experimental: Super 1.000 Mamá

EXPERIMENTAL

Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum.

Dietary Supplement: Fortified powder milk

Sham Comparator: No milk consumption

NO INTERVENTION

Breastfeeding women who have not consumed SMM until the first month postpartum

Interventions

Fortified powder milk DIETARY_SUPPLEMENT

Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.

Experimental: Super 1.000 Mamá

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who have had multiple pregnancies and/or women with malabsorption diseases.

Sponsors & Collaborators

• Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri: lead
• Hospital Interzonal de Agudos General San Martín: collaborator

Study Sites (2)

Hospital Interzonal de Agudos General San Martín

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Central Study Contacts

Maria F Andreoli, PhD

CONTACT

542214177324; mfandreoli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

AR (2)