Bhaktapur Maternal and Child Micronutrient Study

September 15, 2017 updated by: Centre For International Health

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bhaktapur, Nepal, P.O.Box 40
        • Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 11 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2008

Primary Completion (ACTUAL)

February 28, 2010

Study Completion (ACTUAL)

February 28, 2014

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 172226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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