An interventional study of Fortified powder milk in Pregnancy, sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. Recruiting at 2 sites in Argentina. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.
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 ) 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.
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:
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
Breastfeeding women who have not consumed SMM until the first month postpartum
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.
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: 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
Time frame: Mother Zinc concentration will be assessed at one month postpartum
mother Vit E concentration
α-tocopherol concentration in mother serum expressed in μmol/L
Time frame: 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
Time frame: 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
Time frame: Mother's serum DHA concentration will be assessed at one month postpartum
Mother hemoglobin concentration
hemoglobin concentration in mother serum expressed in g/dL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Breast milk Zinc concentration will be assessed at one month postpartum
Breast milk Calcium concentration
Calcium concentration in breast milk expressed in mg/dl
Time frame: Breast milk Calcium concentration will be assessed at one month postpartum
Breast milk Iron concentration
Iron concentration in breast milk expressed in mg/dl
Time frame: Breast milk Iron concentration will be assessed at one month postpartum
Breast milk Iodine concentration
Iodine concentration in breast milk expressed in mg/dl
Time frame: Breast milk Iodine concentration will be assessed at one month postpartum
Mother serum ferritin concentration
ferritin concentration in mother serum expressed in ng/ml
Time frame: 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
Time frame: mother Vit D concentration will be assessed at one month postpartum
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Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri