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临床试验/NCT06287697
NCT06287697进行中(未招募)不适用

Determination of Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia Using the Doubly-Labelled Water (DLW) Technique

Mahidol University1 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2020年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
391
试验地点
1
主要终点
Body composition

研究概览

简要总结

This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

详细描述

The current international recommendations on energy requirements for children aged 6-24 months were established based on data from the Western populations. More human data of healthy children from the developing countries where the living conditions may not be as favourable for child growth and development would be needed to ascertain the validity of the global recommendation. The role of the doubly-labelled water (DLW) technique in measuring total daily energy expenditure to derive energy requirements for humans was also highlighted. Low and middle income countries in Asian countries have undergone the nutrition transition and malnutrition on both ends of the spectrum emerge as significant nutrition challenges during this critical period of growth. Unfortunately, data on body composition, i.e., the relative amounts of fat and lean or fat-free tissue which constitutes quality normal growth beyond anthropometric measurements are scarce. These data will also be needed to guide the infant and young child feeding (IYCF) recommendations for good nutrition and health and to prevent all forms of malnutrition in the region.

This project addressed the need to fill the information gap for the region, and potentially be included for making revision on energy requirement recommendations for infants and young children (IYC) for Asia and beyond. Building on the previous technical cooperation between institutions in Southeast and South Asia with the International Atomic Energy Agency (IAEA) on stable isotopic techniques for health and nutrition well-being, this project is a collaboration between IAEA, FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •for Mothers:
  • •Being aged >18 y old
  • •Being non-smoker
  • •Gestational age at delivery 37-41weeks
  • •Belonging to the major ethnicity of the country
  • •Having any socio-economic status
  • •Willing to sign informed written consent
  • •Inclusion Criteria for Infants:
  • •Healthy baby
  • •Full term
  • •Having birth weight between 2.5 and 4.0 kg
  • •Height-for-age Z score and weight-for-height Z score at or above -2SD
  • •Being exclusively or predominantly breast-fed for at least 3 months

排除标准

  • •for Mothers:
  • •Mothers: having chronic diseases, e.g., gestational diabetes were excluded.
  • •Exclusion Criteria for Infants:
  • •Having inborn errors or chronic diseases e.g., celiac diseases
  • •Taking special supplement, e.g., RUTF.

研究组 & 干预措施

Cross-sectional study-Sri Lanka

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

干预措施: No intervention (Other)

Cross-sectional study-Vietnam

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

干预措施: No intervention (Other)

Cross-sectional study-Pakistan

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

干预措施: No intervention (Other)

Cross-sectional study-Philippines

Children aged 6-8, 9-11, 12-14, 15-17, 18-20, 21-23 months, both sexes.

干预措施: No intervention (Other)

Longitudinal study-Thailand

Cohort 1: 60 children were started at 6-8 months old, and were followed-up at 9-11, 12-14 and 15-17 months old.

Cohort 2: 71 children were started at 12-14 months old, were followed-up 15-17, 18-21 and 21-24 months old.

干预措施: No intervention (Other)

结局指标

主要结局

Body composition

时间窗: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Body composition assessed using doubly labelled water (DLW) technique

Total Energy Expenditure

时间窗: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months

Total Energy Expenditure assessed using doubly labelled water (DLW) technique

次要结局

  • Head circumference(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Dietary intake(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Triceps skinfold thickness(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Weight(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Subscapular skinfold thickness(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Length(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Mid-upper arm circumference(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)
  • Infant and Young Child Feeding (IYCF)(assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tippawan Pongcharoen

Assistant Professor Dr.

Mahidol University

研究点 (1)

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