Bhaktapur Maternal and Child Micronutrient Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Conditions
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Malnutrition, Infant, Malnutrition; Anemia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of micronutrient deficiency | The status and prevalence of deficiencies of several micronutrients has been estimated | 1 year | 
| Predictors for micronutrient status | 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 | 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 | 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. | 5 years | 
| Growth during infancy and at 5 years of age | 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. | 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 | The concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nepal, Breastfeeding, Micronutrients, Women, Infants