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NCT Number: NCT06319079

Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition

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 ) has been designed and developed as part of a key strategy to incorporate in 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 lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.

Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.

To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.

To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.

To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.

To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.

To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.

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Key information

Conditions

Lactating Mothers Infants

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

La Plata, Buenos Aires, 1900, Argentina

Location status: Recruiting

Location contact

Ignacio Agustin I Mendez, MS Nutrition

CONTACT

[email protected]

541158671615 ext. 54221 417-7324

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Super 1.000 Mamá

Powder milk

Other

Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Other names: Commercial powder milk

Primary outcomes

  1. breast milk DHA concentration

    Time frame: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  2. breast milk Vitamin A concentration

    Time frame: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  3. breast milk Vitamin E concentration

    Time frame: breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  4. breast milk Vitamin D concentration

    Time frame: breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  5. breast milk Zinc concentration

    Time frame: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Zinc concentration in breast milk expressed in mg/dl

  6. breast milk Calcium concentration

    Time frame: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Calcium concentration in breast milk expressed in mg/dl

  7. breast milk Iron concentration

    Time frame: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Calcium concentration in breast milk expressed in mg/dl

  8. breast milk Iodine concentration

    Time frame: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Iodine concentration in breast milk expressed in mg/dl

Secondary outcomes

  1. mother red blood cell DHA concentration

    Time frame: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  2. mother Vit A concentration

    Time frame: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Retinol concentration in mother serum expressed in μmol/L

  3. mother Vit E concentration

    Time frame: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  4. mother Vit D concentration

    Time frame: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

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

  5. mother Zinc concentration

    Time frame: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    Zinc concentration in mother serum expressed in mg/dl

  6. mother hemoglobin concentration

    Time frame: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    hemoglobin concentration in mother serum expressed in g/dL

  7. mother serum ferritin concentration

    Time frame: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    ferritin concentration in mother serum expressed in ng/ml

  8. child hemoglobin concentration

    Time frame: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    hemoglobin concentration in child serum expressed in g/dL

  9. child serum ferritin concentration

    Time frame: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    ferritin concentration in child serum expressed in ng/ml

  10. child red blood cell DHA concentration

    Time frame: child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

    concentration of DHA in child red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Florencia Andreoli, PhD

CONTACT

[email protected]

542214177324

Sponsors and collaborators

Lead sponsor

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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