NCT02018588

Brief Summary

Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 9, 2018

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

December 17, 2013

Last Update Submit

February 7, 2018

Conditions

Healthy

Keywords

requirementsamino acidtryptophan

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 hours

Study Arms (1)

tryptophan intake

EXPERIMENTAL

Graded levels of tryptophan will be given to each subject on different study days around the anticipated breakpoint.

Dietary Supplement: tryptophan

Interventions

tryptophanDIETARY_SUPPLEMENT

graded levels of tryptophan will be given to each subject

tryptophan intake

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children age 6-10 inclusive

You may not qualify if:

  • significant recent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30753549DERIVED

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Paul B Pencharz, MD, PhD

    The Hospital for Sick Children, Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute, The Hospital for Sick Children

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 9, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)