Bhaktapur Maternal and Child Micronutrient Study

NCT03285399 | Completed

• 1 other identifier: 172226
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Infant; Malnutrition; Anemia

Keywords

Nepal; Breastfeeding; Micronutrients; Women; Infants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Neurodevelopment at 5 years

  5 years

• Growth during infancy and at 5 years of age

  5 years

• Markers of stress and inflammation.

  1 year

• Breastmilk b-vitamin concentration

  1 year

Eligibility Criteria

• Age: 2 Months - 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• availability of consent
• no ongoing illness
• resides in the selected cluster
• that household information could be obtained
• that the mother was lactating

You may not qualify if:

• refused blood sampling
• chronic illness

Sponsors & Collaborators

• Centre For International Health: lead
• Tribhuvan University, Nepal: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Oslo and Akershus University of Applied Sciences: collaborator

Study Sites (1)

Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan

Bhaktapur, P.O.Box 40, Nepal

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breastmilk Plasma Red blood cells Urine

MeSH Terms

Conditions

Infant Nutrition Disorders; Malnutrition; Anemia; Breast Feeding

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Feeding Behavior; Behavior

Study Officials

• Tor A Strand, MD/PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 18, 2017
• Study Start: January 12, 2008
• Primary Completion: February 28, 2010
• Study Completion: February 28, 2014
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

NE (1)