StuntingMINUTESNCT05779904
Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children
An observational study of Stunting and Development, Child, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Development, Child, DNA Methylation
- How many people
- 300 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Apr 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- twin birth
- congenital malformation
- consanguinity
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Stunting, Development, Child, DNA Methylation, Epigenetics, Nutrition
- Keywords
- Epigenetics signature, Case-control, Under-two-year-old children
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment
Secondary outcomes (3)
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.
Measured: at enrollment
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.
Measured: at enrollment
Gut microbiome
Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq platform
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start5 Apr 2023
- Primary completion31 Dec 2023
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Aberdeen
- Responsible party
- Principal investigator, Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Umi Fahmida, Dr., Principal investigator, SEAMEO RECFON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779904
- Sponsor's protocol ID
- AASH Early Year Study
- Acronym
- MINUTES
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguilar-Farias N, Toledo-Vargas M, Miranda-Marquez S, Cortinez-O'Ryan A, Cristi-Montero C, Rodriguez-Rodriguez F, Martino-Fuentealba P, Okely AD, Del Pozo Cruz B. Sociodemographic Predictors of Changes in Physical Activity, Screen Time, and Sleep among Toddlers and Preschoolers in Chile during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Dec 29;18(1):176. doi: 10.3390/ijerph18010176.
PubMed 33383721Ansari I, Raddatz G, Gutekunst J, Ridnik M, Cohen D, Abu-Remaileh M, Tuganbaev T, Shapiro H, Pikarsky E, Elinav E, Lyko F, Bergman Y. The microbiota programs DNA methylation to control intestinal homeostasis and inflammation. Nat Microbiol. 2020 Apr;5(4):610-619. doi: 10.1038/s41564-019-0659-3. Epub 2020 Feb 3.
PubMed 32015497Bosso M, Thanaraj TA, Abu-Farha M, Alanbaei M, Abubaker J, Al-Mulla F. The Two Faces of ACE2: The Role of ACE2 Receptor and Its Polymorphisms in Hypertension and COVID-19. Mol Ther Methods Clin Dev. 2020 Jun 25;18:321-327. doi: 10.1016/j.omtm.2020.06.017. eCollection 2020 Sep 11.
PubMed 32665962Burchill E, Lymberopoulos E, Menozzi E, Budhdeo S, McIlroy JR, Macnaughtan J, Sharma N. The Unique Impact of COVID-19 on Human Gut Microbiome Research. Front Med (Lausanne). 2021 Mar 16;8:652464. doi: 10.3389/fmed.2021.652464. eCollection 2021.
PubMed 33796545Campagna MP, Xavier A, Lechner-Scott J, Maltby V, Scott RJ, Butzkueven H, Jokubaitis VG, Lea RA. Epigenome-wide association studies: current knowledge, strategies and recommendations. Clin Epigenetics. 2021 Dec 4;13(1):214. doi: 10.1186/s13148-021-01200-8.
PubMed 34863305Carroll N, Sadowski A, Laila A, Hruska V, Nixon M, Ma DWL, Haines J, On Behalf Of The Guelph Family Health Study. The Impact of COVID-19 on Health Behavior, Stress, Financial and Food Security among Middle to High Income Canadian Families with Young Children. Nutrients. 2020 Aug 7;12(8):2352. doi: 10.3390/nu12082352.
PubMed 32784530Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.
PubMed 22968153Development Initiatives (2018). 2018 Global Nutrition Report: Shining a light to spur action on nutrition. Bristol, UK: Development Initiatives.
Development Initiatives Poverty Research. 2020. 2020 Global Nutrition Report: Action on equity to end malnutrition. Bristol, UK: Development Initiatives.
Haggarty P, Hoad G, Campbell DM, Horgan GW, Piyathilake C, McNeill G. Folate in pregnancy and imprinted gene and repeat element methylation in the offspring. Am J Clin Nutr. 2013 Jan;97(1):94-9. doi: 10.3945/ajcn.112.042572. Epub 2012 Nov 14.
PubMed 23151531Haggarty, P., K. Harrison and Haggarty (2017). Population Epigenetics, Springer.
Hannon E, Schendel D, Ladd-Acosta C, Grove J, Hansen CS, Hougaard DM, Bresnahan M, Mors O, Hollegaard MV, Baekvad-Hansen M, Hornig M, Mortensen PB, Borglum AD, Werge T, Pedersen MG, Nordentoft M; iPSYCH-Broad ASD Group; Buxbaum JD, Daniele Fallin M, Bybjerg-Grauholm J, Reichenberg A, Mill J. Variable DNA methylation in neonates mediates the association between prenatal smoking and birth weight. Philos Trans R Soc Lond B Biol Sci. 2019 Apr 15;374(1770):20180120. doi: 10.1098/rstb.2018.0120.
PubMed 30966880Harpham T, Reichenheim M, Oser R, Thomas E, Hamid N, Jaswal S, Ludermir A, Aidoo M. Measuring mental health in a cost-effective manner. Health Policy Plan. 2003 Sep;18(3):344-9. doi: 10.1093/heapol/czg041.
PubMed 12917276He J, Lu YP, Li J, Li TY, Chen X, Liang XJ, Chen WJ, Pi SN, Hocher B, Chen YP. Fetal But Not Maternal Angiotensin Converting Enzyme (ACE)-2 Gene Rs2074192 Polymorphism is Associated with Increased Risk of Being a Small For Gestational Age (SGA) Newborn. Kidney Blood Press Res. 2018;43(5):1596-1606. doi: 10.1159/000494449. Epub 2018 Oct 22.
PubMed 30347406Hoddinott J, Behrman JR, Maluccio JA, Melgar P, Quisumbing AR, Ramirez-Zea M, Stein AD, Yount KM, Martorell R. Adult consequences of growth failure in early childhood. Am J Clin Nutr. 2013 Nov;98(5):1170-8. doi: 10.3945/ajcn.113.064584. Epub 2013 Sep 4.
PubMed 24004889
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05779904
- Acronym / sponsor ID
- MINUTES / AASH Early Year Study
- Conditions
- Stunting, Development, Child, DNA Methylation, Epigenetics, Nutrition
- Keywords
- Epigenetics signature, Case-control, Under-two-year-old children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Aberdeen
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- twin birth
- congenital malformation
- consanguinity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Child congnition outcomes (by psychologists)
Time frame: at enrollment
Child cognition outcomes (care giver reported)
Time frame: at enrollment
Gut microbiome
Time frame: at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 33383721Aguilar-Farias N, Toledo-Vargas M, Miranda-Marquez S, Cortinez-O'Ryan A, Cristi-Montero C, Rodriguez-Rodriguez F, Martino-Fuentealba P, Okely AD, Del Pozo Cruz B. Sociodemographic Predictors of Changes in Physical Activity, Screen Time, and Sleep among Toddlers and Preschoolers in Chile during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Dec 29;18(1):176. doi: 10.3390/ijerph18010176.
- Background: PubMed 32015497Ansari I, Raddatz G, Gutekunst J, Ridnik M, Cohen D, Abu-Remaileh M, Tuganbaev T, Shapiro H, Pikarsky E, Elinav E, Lyko F, Bergman Y. The microbiota programs DNA methylation to control intestinal homeostasis and inflammation. Nat Microbiol. 2020 Apr;5(4):610-619. doi: 10.1038/s41564-019-0659-3. Epub 2020 Feb 3.
- Background: PubMed 32665962Bosso M, Thanaraj TA, Abu-Farha M, Alanbaei M, Abubaker J, Al-Mulla F. The Two Faces of ACE2: The Role of ACE2 Receptor and Its Polymorphisms in Hypertension and COVID-19. Mol Ther Methods Clin Dev. 2020 Jun 25;18:321-327. doi: 10.1016/j.omtm.2020.06.017. eCollection 2020 Sep 11.
- Background: PubMed 33796545Burchill E, Lymberopoulos E, Menozzi E, Budhdeo S, McIlroy JR, Macnaughtan J, Sharma N. The Unique Impact of COVID-19 on Human Gut Microbiome Research. Front Med (Lausanne). 2021 Mar 16;8:652464. doi: 10.3389/fmed.2021.652464. eCollection 2021.
- Background: PubMed 34863305Campagna MP, Xavier A, Lechner-Scott J, Maltby V, Scott RJ, Butzkueven H, Jokubaitis VG, Lea RA. Epigenome-wide association studies: current knowledge, strategies and recommendations. Clin Epigenetics. 2021 Dec 4;13(1):214. doi: 10.1186/s13148-021-01200-8.
- Background: PubMed 32784530Carroll N, Sadowski A, Laila A, Hruska V, Nixon M, Ma DWL, Haines J, On Behalf Of The Guelph Family Health Study. The Impact of COVID-19 on Health Behavior, Stress, Financial and Food Security among Middle to High Income Canadian Families with Young Children. Nutrients. 2020 Aug 7;12(8):2352. doi: 10.3390/nu12082352.
- Background: PubMed 22968153Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.
- BackgroundDevelopment Initiatives (2018). 2018 Global Nutrition Report: Shining a light to spur action on nutrition. Bristol, UK: Development Initiatives.
- BackgroundDevelopment Initiatives Poverty Research. 2020. 2020 Global Nutrition Report: Action on equity to end malnutrition. Bristol, UK: Development Initiatives.
- Background: PubMed 23151531Haggarty P, Hoad G, Campbell DM, Horgan GW, Piyathilake C, McNeill G. Folate in pregnancy and imprinted gene and repeat element methylation in the offspring. Am J Clin Nutr. 2013 Jan;97(1):94-9. doi: 10.3945/ajcn.112.042572. Epub 2012 Nov 14.
- BackgroundHaggarty, P., K. Harrison and Haggarty (2017). Population Epigenetics, Springer.
- Background: PubMed 30966880Hannon E, Schendel D, Ladd-Acosta C, Grove J, Hansen CS, Hougaard DM, Bresnahan M, Mors O, Hollegaard MV, Baekvad-Hansen M, Hornig M, Mortensen PB, Borglum AD, Werge T, Pedersen MG, Nordentoft M; iPSYCH-Broad ASD Group; Buxbaum JD, Daniele Fallin M, Bybjerg-Grauholm J, Reichenberg A, Mill J. Variable DNA methylation in neonates mediates the association between prenatal smoking and birth weight. Philos Trans R Soc Lond B Biol Sci. 2019 Apr 15;374(1770):20180120. doi: 10.1098/rstb.2018.0120.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umi Fahmida, Dr. principal investigator
SEAMEO RECFON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting and Development, Child, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetics signature related to stunting (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779904, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.