Bhaktapur Maternal and Child Micronutrient Study

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Sponsors

Lead Sponsor: Centre For International Health

Collaborator: Tribhuvan University, Nepal
Harvard School of Public Health
Oslo and Akershus University of Applied Sciences

Source 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.

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.

Overall Status Completed
Start Date January 12, 2008
Completion Date February 28, 2014
Primary Completion Date February 28, 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Prevalence of micronutrient deficiency 1 year
Predictors for micronutrient status 1 year
Prevalence of anaemia in mothers and children 1 year
Secondary Outcome
Measure Time Frame
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
Enrollment 1000
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 2 Months

Maximum Age: 11 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tor A Strand, MD/PhD Principal Investigator University of Bergen
Location
Facility: Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
Location Countries

Nepal

Verification Date

September 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov