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Bhaktapur Maternal and Child Micronutrient Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03285399
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Tribhuvan University, Nepal
Harvard School of Public Health
Oslo and Akershus University of Applied Sciences
Information provided by (Responsible Party):
Centre For International Health

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.

Condition or disease
Malnutrition, Infant Malnutrition; Anemia

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.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples Without DNA
Breastmilk Plasma Red blood cells Urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A cross-sectional survey was carried out and 500 healthy lactating women (17-44 years old) were randomly selected from Bhaktapur municipality, Nepal. Bhaktapur is an urban area located 15 km east of the capital Kathmandu and was chosen because of the diversity of this population spanning all socio-economic strata, providing a unique opportunity to explore dietary variation.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03285399

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Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
Bhaktapur, Nepal, P.O.Box 40
Sponsors and Collaborators
Centre For International Health
Tribhuvan University, Nepal
Harvard School of Public Health
Oslo and Akershus University of Applied Sciences
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Principal Investigator: Tor A Strand, MD/PhD University of Bergen

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Responsible Party: Centre For International Health Identifier: NCT03285399     History of Changes
Other Study ID Numbers: 172226
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre For International Health:

Additional relevant MeSH terms:
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Infant Nutrition Disorders
Nutrition Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs