Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05779904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children
Sponsor:
SEAMEO Regional Centre for Food and Nutrition
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINUTES
Brief Summary:
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).
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: