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Completed

NCT Number: NCT03285399

Bhaktapur Maternal and Child Micronutrient Study

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.

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Key information

Age range

2 month–11 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan

Bhaktapur, P.O.Box 40, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of micronutrient deficiency

    Time frame: 1 year

    The status and prevalence of deficiencies of several micronutrients has been estimated

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Centre For International Health

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Oslo and Akershus University of Applied Sciences
  • Tribhuvan University, Nepal

Registry information

Official study title

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Important dates

Study start
2008
Primary completion
2010
Study completion
2014
First posted
Sep 18, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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