Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes

Undernutrition Clinical Trial

Official title:

Association of Early Life Nutritional Related Exposures and Long-term Health and Cognitive Development Outcomes in Adolescents in Northeast, Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979770
• Other study ID #: MU-IRB2012/109.1611
• Secondary ID: COA 2013/008.150
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: March 21, 2018

Study information

• Verified date: January 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the relationship of the various exposures during infancy and childhood on later health and development of adolescents. Various exposures to be assessed include, but not limit to, nutritional status, body composition, energy expenditure, dietary intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.

The study will specifically aim to respond these research questions:

1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2 What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are the factors associated with cognitive functioning during adolescence? Since numerous variables were collected, additional research questions can be possibly studied or other interested variables can be included in the future.

Description:

A longitudinal data were collected in children in the northeast of Thailand beginning at 4-6 months of age and every 2 months through 10-12 months of age while children had been given iron and/or zinc supplementation. Biochemical, anthropometric, socio-demographic, feeding practices, and maternal characteristics data were collected. Children were followed up at 9 years of age to assess the long-term consequences of supplementation and early life nutrition on cognitive functioning and growth. There is a need to continue the follow-up of this study in order to address the association between early nutritional exposures and risks of cardio-metabolic dysfunction and cognitive and behavioral development later in childhood, adolescence and adulthood. Thus, we propose to follow-up these children during adolescence to assess the relationship of early life nutrition and exposures during infancy and childhood and outcomes including nutritional status, cognitive functioning, and risk for non-communicable diseases (NCDs). Findings from this study could provide awareness and information in developing policies and timely interventions to maintain optimal nutritional status throughout vulnerable life stages and reduce risks of NCDs and disabilities later in life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

• Apparently healthy children

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Malnutrition
• Overnutrition
• Undernutrition

Locations

Country	Name	City	State
Thailand	Institute of Nutrition, Mahidol University	Salaya	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardio-vascular fitness	VO2max (L/min)	1 year
Primary	Body composition	Body fat mass (kg), Body fat-free mass (kg) % body fat mass (%), % body fat-free mass (%)	1 year
Secondary	Cognition	IQ scores (IQ point)	1 year