Bhaktapur Maternal and Child Micronutrient Study

Malnutrition, Infant Clinical Trial

Official title:

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285399
• Other study ID #: 172226
• Status: Completed
• Phase: N/A
• First received: September 13, 2017
• Last updated: September 15, 2017
• Start date: January 12, 2008
• Est. completion date: February 28, 2014

Study information

• Verified date: September 2017
• Source: Centre For International Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 28, 2014
• Est. primary completion date: February 28, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 11 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Nutrition Disorders
• Malnutrition
• Malnutrition, Infant
• Malnutrition; Anemia

Locations

Country	Name	City	State
Nepal	Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan	Bhaktapur

Sponsors (4)

Lead Sponsor	Collaborator
Centre For International Health	Harvard School of Public Health, Oslo and Akershus University of Applied Sciences, Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of micronutrient deficiency	The status and prevalence of deficiencies of several micronutrients has been estimated	1 year
Primary	Predictors for micronutrient status	We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.	1 year
Primary	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	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.	5 years
Secondary	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.	5 years
Secondary	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.	1 year
Secondary	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	1 year