Healthy ChildrenNCT04508283
Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study
An observational study of Healthy Children, run by Indonesian Nutrition Association at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 6-36 months are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung
Who may be able to join
- 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
Who cannot join
- Children who are seriously ill and/or need special medication
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Puskesmas Kecamatan Kampung Melayu
Jakarta, DKI Jakarta, 13320
About this 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
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.
Read the 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.
- Conditions
- Healthy Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibre intake profile
Interview the parents about child's food intake using 24-hour food recall and semi-quantitative food frequency questionnaire
Measured: 1 day
Type of milk consumption
Interview the parents about child's milk consumption
Measured: 1 day
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
Measured: 1day
Iron status
Child's blood will be taken for hemoglobin assessment
Measured: 1 day
Nutritional status
Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Mar 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indonesian Nutrition Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saptawati Bardosono, Doctor, Principal investigator, Indonesian Nutrition Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508283
- Sponsor's protocol ID
- INA/FI-20040450
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30005067UNICEF. 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.
PubMed 26754288Widjaja 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.
PubMed 28977637Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
PubMed 18297894
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04508283
- Acronym / sponsor ID
- INA/FI-20040450
- Conditions
- Healthy Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Indonesian Nutrition AssociationUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 6-36 months are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children who are seriously ill and/or need special medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Type of milk consumption
Time frame: 1 day
Interview the parents about child's milk consumption
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
Iron status
Time frame: 1 day
Child's blood will be taken for hemoglobin assessment
Nutritional status
Time frame: 1 day
Nutritional status will be determined using weight-for-age, height-for-age and weight-for-height indicator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- BackgroundHermina 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.
- Background: PubMed 30005067Rakotonirainy 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.
- BackgroundUNICEF. The state of the world's children: Children, food and nutrition: growing well in a changing world 2019.
- BackgroundWellington MoH. Food and Nutrition Guidelines for Healthy Infants and Toddlers (Aged 0- 2): A background paper (4th Ed) - Partially Revised December 2012
- Background: PubMed 26754288Khan 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.
- BackgroundWidjaja IR, Widjaja FF, Sanotos LA, Wonggokusuma, Oktaviati. Anemia among children and adolescents in a rural area. Paediatr Indones 2014;54(2)
- Background: PubMed 28977637Ntenda 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.
- Background: PubMed 18297894Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saptawati Bardosono, Doctor principal investigator
Indonesian Nutrition Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children, run by Indonesian Nutrition Association at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibre intake profile (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508283, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.