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CompletedNCT03285399Updated Sep 18, 2017

Bhaktapur Maternal and Child Micronutrient Study

An observational study in Malnutrition, Infant and Malnutrition; Anemia, sponsored by Centre For International Health. Completed at 1 site in Nepal. Open to participants aged 2 Months to 11 Months. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Centre For International Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
2 Months to 11 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition, Infant
  • Malnutrition; Anemia

Keywords

  • Nepal
  • Breastfeeding
  • Micronutrients
  • Women
  • Infants
03

In context

Infant Nutrition Disorders

67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.

This study's enrollment of 1,000 is above the median of 203 across 20 observational studies indexed under Infant Nutrition Disorders.

Browse Infant Nutrition Disorders studies →

Lead sponsor

Centre For International Health is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 11 Months
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • refused blood sampling
  • chronic illness
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Prevalence of micronutrient deficiency

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

    Time frame: 1 year

  2. Predictors for micronutrient status

    We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 5 years

  2. 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.

    Time frame: 5 years

  3. 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.

    Time frame: 1 year

  4. 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

    Time frame: 1 year

07

Study locations

1 site
  • Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
    Bhaktapur, P.O.Box 40, Nepal
08

References and documents

Individual participant data

Plan to share: Undecided — Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2008 to primary completion in Feb 2010, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2017
First posted
Sep 18, 2017
StartActual
Jan 12, 2008
Primary completionActual
Feb 28, 2010
CompletionActual
Feb 28, 2014
Last update
Sep 18, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03285399
Lead sponsor
Centre For International Health
Collaborators
Tribhuvan University, Nepal, Harvard School of Public Health (HSPH), Oslo and Akershus University of Applied Sciences
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Jan 12, 2008
Primary completion
Feb 28, 2010
Completion
Feb 28, 2014
Last update
Sep 18, 2017

Study contacts

Tor A Strand, MD/PhD
principal investigator · University of Bergen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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