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Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children (MINUTES)

S

SEAMEO Regional Centre for Food and Nutrition

Status

Active, not recruiting

Conditions

DNA Methylation
Development, Child
Nutrition
Stunting
Epigenetics

Study type

Observational

Funder types

Other

Identifiers

NCT05779904
AASH Early Year Study

Details and patient eligibility

About

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).

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 23 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • twin birth
  • congenital malformation
  • consanguinity

Trial design

300 participants in 2 patient groups

Stunted (Case)
Description:
In the case group, stunted children (\<-2SD) (n=150) will be recruited.
Non-stunted (Control)
Description:
In the control group, non-stunted children (\>-1SD) (n=150) will be recruited.

Trial contacts and locations

1

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Central trial contact

Arienta RP Sudibya, M.Sc.; Nur L Zahra, M.Nutr.

Data sourced from clinicaltrials.gov

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