Immune and Scfa Profile of Stunting Children

Stunting Clinical Trial

Official title:

Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698759
• Other study ID #: No.026/VR.RTT/IV/202
• Status: Completed
• Start date: January 9, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: January 2021
• Source: Bina Nusantara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 11, 2020
• Est. primary completion date: October 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Acid
• Growth Disorders
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Stunting

Intervention

Other:
• No Intervention
no Intervention

Locations

Country	Name	City	State
Indonesia	University	Jakarta

Sponsors (4)

Lead Sponsor	Collaborator
Bina Nusantara University	Maastricht University, Universitas Kristen Indonesia, Yayasan Rumah Sakit Islam (YARSI) University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View Citation

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). pii: E1106. doi: 10.3390/nu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiota profile	relative abundance microbiota profile	2 months
Primary	TGF beta	Unit : pg/mL from serum	1 week analysis
Primary	sIgA	Unit : ul/ml from feses extract	1 week analysis
Primary	IL -10	unit pg/ml from serum	1 week analysis
Primary	TNF alfa	unit pg/mL from serum	1 week analysis
Primary	LBP	Unit ul/ml from serum	1 week analysis
Secondary	Short Chain Fatty Acid	Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM	1 months