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Active, Not Recruiting

NCT Number: NCT05779904

Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stunting DNA Methylation Development, Child Epigenetics Growth Disorders Nutrition Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Seameo Recfon

Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Epigenetics signature related to stunting

    Time frame: 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.

Secondary outcomes

  1. Child congnition outcomes (by psychologists)

    Time frame: at enrollment

    Cognitive development will be assessed using the full Bayley Scales of Infant and Toddler Development (BSID-4) by trained psychologists. BSID-4 consists of: Cognitive Scale (COG); Language Scale (LANG), and Motoric Scale (MOT).

    The range of Standard Score (SS) of each scale is 40-160 in which higher score means better.

  2. Child cognition outcomes (care giver reported)

    Time frame: at enrollment

    Cognitive development will be assessed using the care giver reported tool, i.e., INTERGROWTH-21st Neurodevelopment assessment INTER-NDA by trained enumerators. INTER-NDA consists of: Cognitive; Fine motor; Gross motor; Language; Positive behavior; Negative behavior.

    The range of score on each scale is 0 - 100 in which higher score means better.

  3. Gut microbiome

    Time frame: at enrollment

    Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq platform

Sponsors and collaborators

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • University of Aberdeen

Registry information

Official study 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

Acronym: MINUTES

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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