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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01920724
Other study ID # MU-IRB 2010/211.0807
Secondary ID A09/2554
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date July 2012

Study information

Verified date February 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thailand has been facing with the double burden of malnutrition. Many studies in Thailand, which aim to explore the situation, causes, and strategies to prevent obesity, have focused on adults, adolescents, or school-aged children. Few studies have been conducted in preschool children. Obesity or stunting during childhood increases the risk of being obesity in adulthood and leads to chronic diseases. If obesity is established in adulthood, it is difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young children should be highly considered. Study of dietary pattern and reliable field methods to measure fat mass (FM) in children may partly contribute to primary prevention of childhood obesity. The deuterium dilution technique is an accurate and suitable method for children and population-based studies. However, it has not been widely used in children in Thailand. Hence, this study aimed to utilize the deuterium dilution technique for assessing body composition and to determine the quality and quantity of dietary intake among children 3-5 years of age with different nutritional status. We conducted a cross-sectional study in 15 daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were purposively selected according to their nutritional status: stunted, thin, normal, and overweight/obese. Anthropometric measurements were conducted. Body composition was determined based on total body water using deuterium dilution technique. Dietary intake data were obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have more fat mass compared to the normal children.


Description:

Body composition of the children was assessed using the deuterium technique. Total body water (TBW) content was calculated. Then, fat free mass (FFM) and fat mass (FM) was calculated. Weight and height of all children were using a standard technique. Body mass index and nutritional status was calculated using World Health Organization (WHO) growth standard for children 0-5 years. Dietary intake of children was assessed using 2 non-consecutive 24 hour dietary recalls. The 1st and 2nd recall was about 2 weeks apart. Nutrient intake was calculated using the INMUCAL-Nutrients WD. 4.0 (Institute of Nutrition, 2010).


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - Healthy children - Aged 3-5 years - BMI or HAZ fall in the study protocol Exclusion Criteria: - Chronic diseases - Ongoing medical treatments likely to affect body composition - Malformation or muscle diseases

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University International Atomic Energy Agency

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body composition Body fatness 4 months
Secondary Nutrient intake 24 hr recall was perform on a weekend day and a weekday day and nutrient intake was calculated. 4 months
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