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

Infants Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319079
• Other study ID #: UCTH 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Contact: Maria Florencia Andreoli, PhD
• Phone: +542214177324
• Email: mfandreoli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infants

Intervention

Dietary Supplement:
• Fortified powder milk
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:
• Powder milk
Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast milk DHA concentration	concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Vitamin E concentration	a-tocopherol concentration in breast milk expressed in µmol/L and µg/g fat contained in the analyzed sample	breast milk Vitamin E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Vitamin D concentration	25-hidroxi vitamin D concentration in breast milk expressed in ng/ml	breast milk Vitamin D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Zinc concentration	Zinc concentration in breast milk expressed in mg/dl	breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Calcium concentration	Calcium concentration in breast milk expressed in mg/dl	breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Iron concentration	Calcium concentration in breast milk expressed in mg/dl	breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Primary	breast milk Iodine concentration	Iodine concentration in breast milk expressed in mg/dl	breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother red blood cell DHA concentration	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	mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother Vit A concentration	Retinol concentration in mother serum expressed in µmol/L	mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother Vit E concentration	a-tocopherol concentration in mother serum expressed in µmol/L	mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother Vit D concentration	25-hidroxi vitamin D concentration in mother serum expressed in ng/ml	mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother Zinc concentration	Zinc concentration in mother serum expressed in mg/dl	mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother hemoglobin concentration	hemoglobin concentration in mother serum expressed in g/dL	mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	mother serum ferritin concentration	ferritin concentration in mother serum expressed in ng/ml	mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	child hemoglobin concentration	hemoglobin concentration in child serum expressed in g/dL	child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	child serum ferritin concentration	ferritin concentration in child serum expressed in ng/ml	child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary	child red blood cell DHA concentration	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	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)