NCT03285399

Bhaktapur Maternal and Child Micronutrient Study

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Centre For International Health · Academic / Other
• Sex: All
• Age: 2 Months – 11 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition, Infant
• Malnutrition; Anemia

Timeline

• Start date: 2008-01-12
• Primary completion: 2010-02-28
• Completion: 2014-02-28
• First posted: 2017-09-18
• Last updated: 2017-09-18

Locations

1 site across 1 country: Nepal