Clinical trial NCT04508283: Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Children
Lead sponsor: Indonesian Nutrition Association
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6-36 months are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fibre intake profile
timeFrame: 1 day
measure: Type of milk consumption
timeFrame: 1 day
measure: Gastrointestinal symptoms
timeFrame: 1day
measure: Iron status
timeFrame: 1 day
measure: Nutritional status
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Kecamatan Kampung Melayu
state: DKI Jakarta
Study officials:
affiliation: Indonesian Nutrition Association
name: Saptawati Bardosono, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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