Immune and Scfa Profile of Stunting Children

NCT ID: NCT04698759

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-09

Study Completion Date

2020-11-11

Brief Summary

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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. 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. Population and Research Sample The population is children between three and five years old in the village of stunting locus.

The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.

Detailed Description

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The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.

Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.

The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore

1. weight for age (referred as Z-score
2. and weight for height (referred as Z-score
3. .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (\<-3 SD); 'stunted' (-3 SD to \< -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (\> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (\<-3 SD); 'wasted' (-3 SD to \< -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (\> +2 SD to +3 SD); 'obese' (\> +3 SD)

Conditions

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Immune Deficiency Stunting Fatty Acid

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stunted subject

Children with stunted status condition based on Z score criteria

No Intervention

Intervention Type OTHER

no Intervention

Normal subject

Children with normal status condition based on Z score criteria

No Intervention

Intervention Type OTHER

no Intervention

Interventions

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No Intervention

no Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

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

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yayasan Rumah Sakit Islam (YARSI) University

UNKNOWN

Sponsor Role collaborator

Universitas Kristen Indonesia

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

Bina Nusantara University

OTHER

Sponsor Role lead

Responsible Party

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Ingrid S Surono

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid S Surono, PhD

Role: PRINCIPAL_INVESTIGATOR

Bina Nusantara University

Locations

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University

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 17208643 (View on PubMed)

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.

Reference Type RESULT
PMID: 31109058 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34324500 (View on PubMed)

Other Identifiers

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No.026/VR.RTT/IV/202

Identifier Type: -

Identifier Source: org_study_id

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