StuntingNCT04157413
Food-based Approach Development to Fulfil Amino Acid Gap by Considering the Intestinal Permeability of Children
An observational study of Stunting, run by Nia Novita Wirawan.
Trial summary
This study will be comprised of 2 phases. Phase 1 study is a comparative cross-sectional study which will be conducted among children aged 12-24 months living in agricultural area. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2020to 30 Apr 2020
- 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 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Target population of this study are children 12-24 months living in rural agricultural area in Kabupaten Malang. Kecamatan will be chosen based on the high prevalence of stunting and having potentials of protein food source to be optimized. Sample of the study are children living in selected villages in the period of 2019-2020 who fulfill the inclusion criteria.
Who may be able to join
- Stunting group is defined as length for age Z-score (LAZ) <-2.0 SD and non-stunting group as LAZ ≥-0.5 SD
- Normal weight for length Z-score (WLZ ≥-2 SD to ≤+1 SD)
- Group matching by age, gender
- Singleton
- Full term gestation
- Normal birth weight
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- Living with mother
- Not suffered from diarrhea at least in the last 1 month (as reported by the mothers)
- Not suffering from fever during assessment (as measured by the health staff)
- Not born from diabetic mothers (as reported by the mothers)
Who cannot join
- Drink Ultra High Temperature (UHT) milk at least 15 days before urine collection
- Taking any medication.
- Had taken non-steroidal anti-inflammatory drugs within two weeks of the study,
- Taken antibiotics within 4 weeks of the study,
- Unable to drink the sugar solution
- Refuse to participate until completion of the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Essential Amino Acid Intake and Intestinal Permeability on Amino Acid Blood Profile and Linear Growth Among Indonesian Children 12-24 Months Living in an Agricultural Area: A Basis for a Food Based Intervention
This study will be comprised of 2 phases. Phase 1 study is a comparative cross-sectional study which will be conducted among children aged 12-24 months living in agricultural area. A total of 172 healthy children consisted of 86 stunted children (Length for age z-score <-2 Standard deviation) and 86 non-stunted children (Length for age z-score ≥0.5 Standard Deviation) will be recruited. Dietary intake, urine and dried blood spot from finger prick will be collected to assess amino acid intake, intestinal permeability and essential blood amino acid respectively. Qualitative study i.e. focus group discussion (FGD) and market survey will also be implemented. According to the result of phase 1 study, 2 types of food-based approaches will be developed, namely Complementary food recommendations (CFR) and Food multi-mix formula
Read the detailed description
Phase 1 study will recruit a total of 172 healthy children who are matched by sex and age. Aside of being stunted, children must have normal weight for length z-score (not wasted or overweight). Data collection will be performed as follows:
- Dietary intake of the children will be collected by 9 days Estimated Food Record by visiting the respondents house
- Urine will be collected once to measure intestinal permeability profile using Lactulose Mannitol ratio indicator.
- Dried blood spot from finger prick will be collected to essential blood amino acid.
To collect information on locally available and culturally accepted protein rich food sources, series of focus group discussion (FGD) and market survey will also be implemented.
Food-based approaches will be developed according to the information attained from phase 1 study. Problem nutrients that are identified from dietary assessment will be fulfilled through optimization of locally available food by using linear programming approach. Problem nutrients that are not able to be fulfilled by CFR will be use as a basis to develop a Food multi-mix (FMM) formula. Data of intestinal permeability profile will be used to add other locally available food in FMM that are potential to improve intestinal permeability.
- Conditions
- Stunting
- Keywords
- amino acid intake, blood amino acid, stunting, linear growth, intestinal permeability, lactulose mannitol ratio
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stunted Group | A comparative cross sectional study will compare stunted group and non-stunted group on amino acid intake, blood amino acid and intestinal permeability. Stunted group is defined as children who have LAZ <-2 SD | |
| Non-stunted Group | Non-stunted group will be those with LAZ >= 0.5 SD matching by age and sex with stunted group. Other criteria will be similar. No Intervention will be given to the groups in this proposed protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid intake
Amino acid intake will be assessed by estimated food record
Measured: January - February 2020
Blood amino acid
Essential blood amino acid will be measured from finger prick dried blood spot and will be analyzed using LC-MS/MS
Measured: January - April 2020
Intestinal Permeability
Intestinal permeability will be measured from urine and will be analyzed using HPLC
Measured: January-April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start2 Jan 2020 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nia Novita Wirawan
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Sponsor-investigator, Nia Novita Wirawan, University of Brawijaya
- Investigators
- Badriul S Hegar, Prof, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157413
- Sponsor's protocol ID
- l9-10-1169
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will not share the IPD of the subject participated due to consent issue
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Essential Amino Acid Intake and Intestinal Permeability on Amino Acid Blood Profile and Linear Growth Among Indonesian Children 12-24 Months Living in an Agricultural Area: A Basis for a Food Based Intervention
- ClinicalTrials.gov ID
- NCT04157413
- Acronym / sponsor ID
- l9-10-1169
- Conditions
- Stunting
- Keywords
- amino acid intake, blood amino acid, stunting, linear growth, intestinal permeability, lactulose mannitol ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Nia Novita WirawanUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- 2 Jan 2020 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 8 Nov 2019 (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.
This study will be comprised of 2 phases. Phase 1 study is a comparative cross-sectional study which will be conducted among children aged 12-24 months living in agricultural area. A total of 172 healthy children consisted of 86 stunted children (Length for age z-score <-2 Standard deviation) and 86 non-stunted children (Length for age z-score ≥0.5 Standard Deviation) will be recruited. Dietary intake, urine and dried blood spot from finger prick will be collected to assess amino acid intake, intestinal permeability and essential blood amino acid respectively. Qualitative study i.e. focus group discussion (FGD) and market survey will also be implemented. According to the result of phase 1 study, 2 types of food-based approaches will be developed, namely Complementary food recommendations (CFR) and Food multi-mix formula
Detailed description
Phase 1 study will recruit a total of 172 healthy children who are matched by sex and age. Aside of being stunted, children must have normal weight for length z-score (not wasted or overweight). Data collection will be performed as follows:
- Dietary intake of the children will be collected by 9 days Estimated Food Record by visiting the respondents house
- Urine will be collected once to measure intestinal permeability profile using Lactulose Mannitol ratio indicator.
- Dried blood spot from finger prick will be collected to essential blood amino acid.
To collect information on locally available and culturally accepted protein rich food sources, series of focus group discussion (FGD) and market survey will also be implemented.
Food-based approaches will be developed according to the information attained from phase 1 study. Problem nutrients that are identified from dietary assessment will be fulfilled through optimization of locally available food by using linear programming approach. Problem nutrients that are not able to be fulfilled by CFR will be use as a basis to develop a Food multi-mix (FMM) formula. Data of intestinal permeability profile will be used to add other locally available food in FMM that are potential to improve intestinal permeability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stunted Group | – | –A comparative cross sectional study will compare stunted group and non-stunted group on amino acid intake, blood amino acid and intestinal permeability. Stunted group is defined as children who have LAZ <-2 SD |
| Non-stunted Group | – | –Non-stunted group will be those with LAZ >= 0.5 SD matching by age and sex with stunted group. Other criteria will be similar. No Intervention will be given to the groups in this proposed protocol. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Target population of this study are children 12-24 months living in rural agricultural area in Kabupaten Malang. Kecamatan will be chosen based on the high prevalence of stunting and having potentials of protein food source to be optimized. Sample of the study are children living in selected villages in the period of 2019-2020 who fulfill the inclusion criteria.
Key inclusion criteria (10 listed)
- Stunting group is defined as length for age Z-score (LAZ) <-2.0 SD and non-stunting group as LAZ ≥-0.5 SD
- Normal weight for length Z-score (WLZ ≥-2 SD to ≤+1 SD)
- Group matching by age, gender
- Singleton
- Full term gestation
Key exclusion criteria (6 listed)
- Drink Ultra High Temperature (UHT) milk at least 15 days before urine collection
- Taking any medication.
- Had taken non-steroidal anti-inflammatory drugs within two weeks of the study,
- Taken antibiotics within 4 weeks of the study,
- Unable to drink the sugar solution
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
Amino acid intake
Time frame: January - February 2020
Amino acid intake will be assessed by estimated food record
Blood amino acid
Time frame: January - April 2020
Essential blood amino acid will be measured from finger prick dried blood spot and will be analyzed using LC-MS/MS
Intestinal Permeability
Time frame: January-April 2020
Intestinal permeability will be measured from urine and will be analyzed using HPLC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No. I will not share the IPD of the subject participated due to consent issue
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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.
Badriul S Hegar, Prof study chair
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting, run by Nia Novita Wirawan.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nia N Wirawan, MSc. (+628129674654, niawirawan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid intake (time frame: January - February 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2019.