DNA Methylation, Microbiome Profile, Nutritional Status, and Developmental Outcomes of Stunted and Non-stunted Children Growing up During Covid-19 Pandemic: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Epigenetics signature related to stunting
研究概览
简要总结
The investigators will conduct a case-control study among under-two children in Lombok Timur, West Nusa Tenggara, Indonesia. The power required to detect changes in epigenetic markers may not be sufficient in the cohort study. Therefore, specific case-control design of stunted vs non-stunted children will provide the required power to detect potential epigenetic markers which will be further investigated through targeted sequencing of the cohort study. A total of 150 stunted children will be recruited and then it will be matched with 150 non-stunted children with the same sex. The assessments for these study subjects will include: 1) The genetic and epigenetic profile of the children, gut microbiota and nutritional status (Physical component), 2) Food security, Water, Sanitation and Hygiene (WASH) and Infant and Young Child Feeding (IYCF) practices (Home-Food component), 3) Children's psychosocial care and cognitive outcome (Cognition component).
详细描述
This study is part of Action Against Stunting Hub, an observational cohort study aimed to build evidence based on exploring the drivers of stunting from different perspectives and understand the impact of different interventions across three countries: India, Indonesia and Senegal. This study is intended to give the overview of stunting and its determinants among under-two children growing up during period of Covid-19 pandemic in Lombok Timur, Nusa Tenggara Barat, Indonesia. Because, the power required to detect changes in epigenetic markers may not be sufficient in the cohort study, this specific case-control design of stunted vs non-stunted children will also provide the required power to detect potential epigenetic markers which will be further investigated through targeted sequencing of the cohort study. The results of this initial study are projected to support further study, especially the observational cohort study, in determining the best suited indicators to prove the interaction and/or causal mechanisms of stunting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18.0 - 23.9 months
- •without serious illnesses
- •the mother delivered the children between 18-40 years of age
- •has Sasak ethnicity, (5) recumbent length <-2SD (for stunted group) and >-1SD (for non- stunted group) from the WHO Child Growth Standards median for their age and sex at the recruitment.
排除标准
- •twin birth
- •congenital malformation
- •consanguinity
结局指标
主要结局
Epigenetics signature related to stunting
时间窗: at enrollment
Analysis of epigenetic states (DNA methylation) will be carried out using the Illumina Infinium Methylation EPIC V.2.0 BeadChip, augmented by sequencing methodologies to provide both genome wide coverage and high-definition analysis. Epigenetic state controls gene expression and overall genome regulation at scale and the study will focus on candidate epigenetic states implicated in stunting and its corollaries alongside epigenome wide association.
次要结局
- Child cognition outcomes (care giver reported)(at enrollment)
- Gut microbiome(at enrollment)
- Child congnition outcomes (by psychologists)(at enrollment)
研究者
Dr.Umi Fahmida
Principal Investigator
SEAMEO Regional Centre for Food and Nutrition