- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508283
Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study
Fiber Intake Profile Among Children 6-36 Months in Relation to Type of Milk Consumption, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study in Jakarta and Bandung, Indonesia
Study Overview
Status
Conditions
Detailed Description
This study is an observational cross-sectional study to get fiber intake profile among children aged 6-36 months in relation to cow's and non-cow's milk consumption, gastrointestinal symptoms, hemoglobin value and nutritional status. The participants in this study are children aged 6-36 months who are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung after provided with informed consent from children's parents. To get proportion of low fiber intake with a degree of reliability 95% and significance level of 5%, then 400 subjects is needed as a minimal sample size in this study.
The children's parents will be interviewed about socio-demographic characteristics of the subjects, gastrointestinal symptoms during the past two weeks using VAS (Visual Analogue Scale) on frequency of bowel movements in a week, parents's education, family income, and child's food intake. The children's weight and height will be measured and blood sample will be taken.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Saptawati Bardosono, Doctor
- Phone Number: +62817149629
- Email: tati.bardo@yahoo.com
Study Contact Backup
- Name: Diana Sunardi, Doctor
- Phone Number: +628161646427
- Email: diana_sunardi@yahoo.com
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 13320
- Puskesmas Kecamatan Kampung Melayu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 6-36 months who are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung after provided with informed consent from their parents
Exclusion Criteria:
- Children who are seriously ill and/or need special medication
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibre intake profile
Time Frame: 1 day
|
Interview the parents about child's food intake using 24-hour food recall and semi-quantitative food frequency questionnaire
|
1 day
|
Type of milk consumption
Time Frame: 1 day
|
Interview the parents about child's milk consumption
|
1 day
|
Gastrointestinal symptoms
Time Frame: 1day
|
Interview the parents about child's gastrointestinal symptoms during the past two weeks using VAS on frequency of bowel movements in a week, the presence of difficulty when passing a bowel movement, bloating, abdominal pain/colic, and flatulence, into four scale, i.e. 0 = never, 1 = rarely, 2 = frequently, or 3 = all the time
|
1day
|
Iron status
Time Frame: 1 day
|
Child's blood will be taken for hemoglobin assessment
|
1 day
|
Nutritional status
Time Frame: 1 day
|
Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saptawati Bardosono, Doctor, Indonesian Nutrition Association
Publications and helpful links
General Publications
- Hermina and Prihartini. Fruits and vegetables consumption of Indonesian population in the context of balanced nutrition: A Further Analysis of Individual Food Consumption Survey (SKMl). Buletin Penelitian Kesehatan (Health Research Bulletin);2016;44(3): 205-218.
- Rakotonirainy NH, Razafindratovo V, Remonja CR, Rasoloarijaona R, Piola P, Raharintsoa C, Randremanana RV. Dietary diversity of 6- to 59-month-old children in rural areas of Moramanga and Morondava districts, Madagascar. PLoS One. 2018 Jul 13;13(7):e0200235. doi: 10.1371/journal.pone.0200235. eCollection 2018.
- UNICEF. The state of the world's children: Children, food and nutrition: growing well in a changing world 2019.
- Wellington MoH. Food and Nutrition Guidelines for Healthy Infants and Toddlers (Aged 0- 2): A background paper (4th Ed) - Partially Revised December 2012
- Khan JR, Awan N, Misu F. Determinants of anemia among 6-59 months aged children in Bangladesh: evidence from nationally representative data. BMC Pediatr. 2016 Jan 11;16:3. doi: 10.1186/s12887-015-0536-z.
- Widjaja IR, Widjaja FF, Sanotos LA, Wonggokusuma, Oktaviati. Anemia among children and adolescents in a rural area. Paediatr Indones 2014;54(2)
- Ntenda PAM, Chuang KY, Tiruneh FN, Chuang YC. Multilevel Analysis of the Effects of Individual- and Community-Level Factors on Childhood Anemia, Severe Anemia, and Hemoglobin Concentration in Malawi. J Trop Pediatr. 2018 Aug 1;64(4):267-278. doi: 10.1093/tropej/fmx059.
- Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- INA/FI-20040450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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