NCT04698759

Brief Summary

  1. 1.Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
  2. 2.Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
  3. 3.Population and Research Sample The population is children between three and five years old in the village of stunting locus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 5, 2021

Last Update Submit

January 13, 2021

Conditions

Immune DeficiencyStuntingFatty Acid

Keywords

immune statusstuntingNormal Nutritional StatusIndonesian ChildrenGut MicrobiotaSCFA

Outcome Measures

Primary Outcomes (5)

  • TGF beta

    Unit : pg/mL from serum

    1 week analysis

  • sIgA

    Unit : ul/ml from feses extract

    1 week analysis

  • IL -10

    unit pg/ml from serum

    1 week analysis

  • TNF alfa

    unit pg/mL from serum

    1 week analysis

  • LBP

    Unit ul/ml from serum

    1 week analysis

Secondary Outcomes (1)

  • Short Chain Fatty Acid

    1 months

Other Outcomes (1)

  • Microbiota profile

    2 months

Study Arms (2)

Stunted subject

Children with stunted status condition based on Z score criteria

Other: No Intervention

Normal subject

Children with normal status condition based on Z score criteria

Other: No Intervention

Interventions

No InterventionOTHER

no Intervention

Normal subjectStunted subject

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

.A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).

You may qualify if:

  • Children age : 3 - 5 years old (36-60 months)
  • Live in the research area
  • Apparently healthy children, after examination by a physician
  • Involved in a research study (informed consent signed by parent or guardian)

You may not qualify if:

  • Children age \< 36 month and \> 60 month
  • Live outside research area
  • Unhealthy, after examination by a physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Jakarta, Indonesia

Location

Related Publications (3)

  • Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.

    PMID: 17208643BACKGROUND

  • Titaley CR, Ariawan I, Hapsari D, Muasyaroh A, Dibley MJ. Determinants of the Stunting of Children Under Two Years Old in Indonesia: A Multilevel Analysis of the 2013 Indonesia Basic Health Survey. Nutrients. 2019 May 18;11(5):1106. doi: 10.3390/nu11051106.

    PMID: 31109058RESULT

  • Surono IS, Jalal F, Bahri S, Romulo A, Kusumo PD, Manalu E, Yusnita, Venema K. Differences in immune status and fecal SCFA between Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jul 29;16(7):e0254300. doi: 10.1371/journal.pone.0254300. eCollection 2021.

    PMID: 34324500DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample with plasma and serum preparation Fecal sample with DNA extraction Fecal sample with SCFA preparation

MeSH Terms

Conditions

Immunologic Deficiency SyndromesGrowth Disorders

Condition Hierarchy (Ancestors)

Immune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ingrid S Surono, PhD

    Bina Nusantara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

January 9, 2020

Primary Completion

October 11, 2020

Study Completion

November 11, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)