Skip to main content
OpenTrials
Completed

NCT Number: NCT04508283

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Children

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Puskesmas Kecamatan Kampung Melayu

Jakarta, DKI Jakarta, 13320, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Type of milk consumption

    Time frame: 1 day

    Interview the parents about child's milk consumption

  3. 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

  4. Iron status

    Time frame: 1 day

    Child's blood will be taken for hemoglobin assessment

  5. Nutritional status

    Time frame: 1 day

    Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator

Sponsors and collaborators

Lead sponsor

Indonesian Nutrition Association

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.