HealthyNCT02018588
Tryptophan Requirement of Healthy School Age Children
A study testing tryptophan in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tryptophan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Dec 2017
- Phase
- Interventional
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children age 6-10 inclusive
Who cannot join
- significant recent illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tryptophan Requirement of Healthy School Age Children Determined by the Indicator Amino Acid Oxidation Method
Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.
Read the detailed description
Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.
- Conditions
- Healthy
- Being tested
- tryptophan
- Keywords
- requirements, amino acid, tryptophan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tryptophanDietary supplement
graded levels of tryptophan will be given to each subject
| Study group | Role | What they receive |
|---|---|---|
| tryptophan intake | Experimental | Graded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint. Receives: Dietary Supplement: tryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of tryptophan in school age children
By collection of stable isotope labeled CO2 from the indicator amino acid phenylalanine in response to different intake levels of tryptophan we will be able to determine tryptophan requirements.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Pencharz, The Hospital for Sick Children
- Investigators
- Paul B Pencharz, MD, PhD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018588
- Sponsor's protocol ID
- 0019850580T
- Status last verified
- Apr 2017
- First submitted
- 17 Dec 2013
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Al-Mokbel A, Courtney-Martin G, Elango R, Ball RO, Pencharz PB, Tomlinson C. Tryptophan Requirement in School-Age Children Determined by the Indicator Amino Acid Oxidation Method is Similar to Current Recommendations. J Nutr. 2019 Feb 1;149(2):280-285. doi: 10.1093/jn/nxy250.
PubMed 30753549
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan Requirement of Healthy School Age Children Determined by the Indicator Amino Acid Oxidation Method
- ClinicalTrials.gov ID
- NCT02018588
- Acronym / sponsor ID
- 0019850580T
- Conditions
- Healthy
- Keywords
- requirements, amino acid, tryptophan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.
Detailed description
Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tryptophan intake | Experimental | Dietary Supplement: tryptophanGraded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children age 6-10 inclusive
Key exclusion criteria (1 listed)
- significant recent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tryptophangraded levels of tryptophan will be given to each subject | Dietary supplement | tryptophan intake |
Primary outcome
Requirement of tryptophan in school age children
Time frame: 4 hours
By collection of stable isotope labeled CO2 from the indicator amino acid phenylalanine in response to different intake levels of tryptophan we will be able to determine tryptophan requirements.
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 9 Feb 2018.
- Derived from this study: PubMed 30753549Al-Mokbel A, Courtney-Martin G, Elango R, Ball RO, Pencharz PB, Tomlinson C. Tryptophan Requirement in School-Age Children Determined by the Indicator Amino Acid Oxidation Method is Similar to Current Recommendations. J Nutr. 2019 Feb 1;149(2):280-285. doi: 10.1093/jn/nxy250.
- 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.
Paul B Pencharz, MD, PhD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tryptophan in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
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 9 Feb 2018. 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 Canada. 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?
Requirement of tryptophan in school age children (time frame: 4 hours). 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 NCT02018588, which also lists 1 linked publication.
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 9 Feb 2018.