- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03285399
Bhaktapur Maternal and Child Micronutrient Study
Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bhaktapur, Nepal, P.O.Box 40
- Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- availability of consent
- no ongoing illness
- resides in the selected cluster
- that household information could be obtained
- that the mother was lactating
Exclusion Criteria:
- refused blood sampling
- chronic illness
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of micronutrient deficiency
Time Frame: 1 year
|
The status and prevalence of deficiencies of several micronutrients has been estimated
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1 year
|
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.
|
1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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5 years
|
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.
|
5 years
|
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.
|
1 year
|
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
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1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 172226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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