Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study

Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508283
• Other study ID #: INA/FI-20040450
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2023
• Source: Indonesian Nutrition Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fiber as part of the plants can be provided through eating grains, fruits and vegetables. As source of fiber, exclusively breastfed infants do not need additional dietary fiber because breast-milk provides oligosaccharides to maintain the bulk for normal gastrointestinal movements together with gut probiotics. However, after the period of six months of exclusive breastfeeding, then complementary foods are the initial sources of fiber of children aged 6-59 months diet, e.g. cereals, fruits and legumes should then be introduced. However, investigators should consider on the effect of plant foods as a non-haem iron food source that is less bioavailable for iron absorption. There are other dietary factors that inhibit iron bioavailability, i.e. phytates in grains and rice, vegetables protein, calcium and phosphorus in cow's milk and cheese. iron deficiency is remained common globally, especially for children age 6-24 month in which it can developing into a severe condition, i.e. iron deficiency anemia. Iron deficiency as well as anemia is closely related to delay child growth and development, negatively associated with height-for-age, and anemia are at risk for poorer cognitive, motor, social-emotional, and neurophysiologic development in the short- and long-term outcome. The aim of this study is to see the association between fiber intake from different type of milk consumption sources and dietary habits to gastrointestinal health, anemia and growth status among children aged 6-36 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy Children

Locations

Country	Name	City	State
Indonesia	Puskesmas Kecamatan Kampung Melayu	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesian Nutrition Association

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

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.

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. — View Citation

Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409. — View Citation

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. — View Citation

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. — View Citation

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

Widjaja IR, Widjaja FF, Sanotos LA, Wonggokusuma, Oktaviati. Anemia among children and adolescents in a rural area. Paediatr Indones 2014;54(2)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibre intake profile	Interview the parents about child's food intake using 24-hour food recall and semi-quantitative food frequency questionnaire	1 day
Primary	Type of milk consumption	Interview the parents about child's milk consumption	1 day
Primary	Gastrointestinal symptoms	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
Primary	Iron status	Child's blood will be taken for hemoglobin assessment	1 day
Primary	Nutritional status	Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator	1 day