Bhaktapur Maternal and Child Micronutrient Study
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|ClinicalTrials.gov Identifier: NCT03285399|
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
|Condition or disease|
|Malnutrition, Infant Malnutrition; Anemia|
Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. The women attended a hospital for physical examination, dietary interview, and blood sampling. Blood samples were also collected from their infants who also went through a detailed clinical examination
The blood samples from mothers and infant pairs were collected approximately one week apart. The blood was spun down, plasma separated and transferred into storage vials immediately. Plasma and blood pellets were stored in cryovials at -70 until analysis.
All women were also requested to provide one breast milk and one urine sample.
Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis.
Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A, vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.
The breast milk will be analyzed for iodine, fatty acids, and several B vitamins
The urine was analyzed for iodine.
In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food security, and neurodevelopment.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal|
|Actual Study Start Date :||January 12, 2008|
|Actual Primary Completion Date :||February 28, 2010|
|Actual Study Completion Date :||February 28, 2014|
- Prevalence of micronutrient deficiency [ Time Frame: 1 year ]The status and prevalence of deficiencies of several micronutrients has been estimated
- Predictors for micronutrient status [ Time Frame: 1 year ]We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.
- Prevalence of anaemia in mothers and children [ Time Frame: 1 year ]Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.
- Neurodevelopment at 5 years [ Time Frame: 5 years ]Neurodevelopment is measured when the children are 5 using the Ages and Stages questionnaire and the NEPSY II tests. These measures will be related to micronutrient status, inflammation and stress markers.
- Growth during infancy and at 5 years of age [ Time Frame: 5 years ]Growth (length and weight) is measured when the children are 5 years and will be related to nutritional status.
- Markers of stress and inflammation. [ Time Frame: 1 year ]Maternal and infants markers of inflammation (CRP, neopterine, kynurenic acid, kynurenine, tryphtophane, etc) and stress (leucocyte telomere length) will be measured and related to micronutrient status.
- Breastmilk b-vitamin concentration [ Time Frame: 1 year ]The concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285399
|Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan|
|Bhaktapur, Nepal, P.O.Box 40|
|Principal Investigator:||Tor A Strand, MD/PhD||University of Bergen|