Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319079
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-12
Brief Title:
Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
Sponsor:
Instituto de Desarrollo e Investigaciones Pediátricas Prof Dr Fernando E Viteri
Organization:
Instituto de Desarrollo e Investigaciones Pediátricas Prof Dr Fernando E Viteri
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None