An interventional study of Fortified powder milk and Powder milk in Lactating Mothers and Infants, sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. Recruiting at 1 site in Argentina. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Not applicable, Interventional, and Prevention
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.
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Fortified powder milk
Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk.
Other: 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.
Also known as: Super 1.000 Mamá
Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.
Also known as: Commercial powder milk
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
Time frame: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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
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)
breast milk Vitamin E concentration
α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
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)
breast milk Vitamin D concentration
25-hidroxi vitamin D concentration in breast milk expressed in ng/ml
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)
breast milk Zinc concentration
Zinc concentration in breast milk expressed in mg/dl
Time frame: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Calcium concentration
Calcium concentration in breast milk expressed in mg/dl
Time frame: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iron concentration
Calcium concentration in breast milk expressed in mg/dl
Time frame: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iodine concentration
Iodine concentration in breast milk expressed in mg/dl
Time frame: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
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
Time frame: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit A concentration
Retinol concentration in mother serum expressed in μmol/L
Time frame: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit E concentration
α-tocopherol concentration in mother serum expressed in μmol/L
Time frame: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit D concentration
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
Time frame: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Zinc concentration
Zinc concentration in mother serum expressed in mg/dl
Time frame: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother hemoglobin concentration
hemoglobin concentration in mother serum expressed in g/dL
Time frame: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother serum ferritin concentration
ferritin concentration in mother serum expressed in ng/ml
Time frame: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child hemoglobin concentration
hemoglobin concentration in child serum expressed in g/dL
Time frame: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child serum ferritin concentration
ferritin concentration in child serum expressed in ng/ml
Time frame: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
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
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)
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Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri