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

NCT05779904 | Active Not Recruiting DMC

• 1 other identifier: AASH Early Year Study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Stunting; Development, Child; DNA Methylation; Epigenetics; Nutrition

Keywords

Epigenetics signature; Case-control; Under-two-year-old children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Child congnition outcomes (by psychologists)

  at enrollment

• Child cognition outcomes (care giver reported)

  at enrollment

• Gut microbiome

  at enrollment

Study Arms (2)

Stunted (Case)

In the case group, stunted children (\<-2SD) (n=150) will be recruited.

Non-stunted (Control)

In the control group, non-stunted children (\>-1SD) (n=150) will be recruited.

Eligibility Criteria

• Age: 18 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A total of 150 stunted children (case) will be recruited and then it will be matched with 150 non-stunted children (control) with the same sex. Before the screening time, data of children aged 18.0-23.9 months from Posyandu will be listed. The field team will coordinate with midwives to inform the children and their guardian to get screened. Screening for eligibility criteria will be done for all children aged 18.0-23.9 months that has listed in the previous visit. Length measurement for the children and checklist of eligibility criteria will be done during the screening time by trained enumerators. After fulfilling the eligibility criteria, the enumerators have to determine to matched children based on their gender.

You may qualify if:

• 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.

You may not qualify if:

• twin birth
• congenital malformation
• consanguinity

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead
• London School of Hygiene and Tropical Medicine: collaborator
• University of Aberdeen: collaborator

Study Sites (1)

Seameo Recfon

Jakarta, 10430, Indonesia

Location

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MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Umi Fahmida, Dr.

  SEAMEO RECFON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 22, 2023
• Study Start: April 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: September 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)