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Bhaktapur Maternal and Child Micronutrient Study

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03285399
Enrollment
1000
Registered
2017-09-18
Start date
2008-01-12
Completion date
2014-02-28
Last updated
2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition; Anemia, Malnutrition, Infant

Keywords

Nepal, Breastfeeding, Micronutrients, Women, Infants

Brief summary

Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

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.

Interventions

None listed

Sponsors

Tribhuvan University, Nepal
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Oslo and Akershus University of Applied Sciences
CollaboratorUNKNOWN
Centre For International Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Months to 11 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of micronutrient deficiency1 yearThe status and prevalence of deficiencies of several micronutrients has been estimated
Predictors for micronutrient status1 yearWe will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.
Prevalence of anaemia in mothers and children1 yearHemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.

Secondary

MeasureTime frameDescription
Neurodevelopment at 5 years5 yearsNeurodevelopment 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.
Breastmilk b-vitamin concentration1 yearThe concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status
Growth during infancy and at 5 years of age5 yearsGrowth (length and weight) is measured when the children are 5 years and will be related to nutritional status.
Markers of stress and inflammation.1 yearMaternal 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.

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026