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

Nutrition Clinical Trial

— MINUTES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05779904
• Other study ID #: AASH Early Year Study
• Status: Not yet recruiting
• Start date: March 31, 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: SEAMEO Regional Centre for Food and Nutrition
• Contact: Arienta RP Sudibya, M.Sc.
• Phone: +628118113811
• Email: arientasudibya[@]seameo-recfon.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Development, Child
• DNA Methylation
• Epigenetics
• Growth Disorders
• Nutrition
• Stunting

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SEAMEO Regional Centre for Food and Nutrition	London School of Hygiene and Tropical Medicine, University of Aberdeen

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetics signature related to stunting	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.	at enrollment
Secondary	Child congnition outcomes (by psychologists)	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.	at enrollment
Secondary	Child cognition outcomes (care giver reported)	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.	at enrollment
Secondary	Gut microbiome	Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq and BSAS.	at enrollment