Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
- Conditions
- Lactating MothersInfants
- Interventions
- Other: Powder milkDietary Supplement: Fortified powder milk
- Registration Number
- NCT06319079
- Lead Sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- 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 ) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Leche comercial Powder milk Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk. Super 1.000 Mamá Fortified powder milk Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population.
- Primary Outcome Measures
Name Time Method breast milk Vitamin E concentration 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
breast milk Vitamin A concentration 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
breast milk DHA concentration 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
breast milk Iron concentration 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
breast milk Zinc concentration 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
breast milk Vitamin D concentration 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
breast milk Calcium concentration 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
breast milk Iodine concentration 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 Outcome Measures
Name Time Method mother Vit E concentration 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
child serum ferritin concentration 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
mother Vit D concentration 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
mother Zinc concentration 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
mother serum ferritin concentration 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
mother red blood cell DHA concentration 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
mother Vit A concentration 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
mother hemoglobin concentration 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
child hemoglobin concentration 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
child red blood cell DHA concentration 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
Trial Locations
- Locations (1)
Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
🇦🇷La Plata, Buenos Aires, Argentina