NCT00227136

Brief Summary

This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the urine can be found in a specific type of cancer, called carcinoid tumor. This study will examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

April 13, 2018

Status Verified

July 1, 2006

First QC Date

September 23, 2005

Last Update Submit

April 11, 2018

Conditions

Carcinoid TumorsNeuroendocrine Tumors

Keywords

5HydroxytryptamineChromogranin A5HIAAcarcinoid

Outcome Measures

Primary Outcomes (2)

  • Urinary excretion of 5-HIAA

  • Plasma Chromogranin A

Secondary Outcomes (1)

  • Side effects

Interventions

5-Hydroxy-TryptamineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • in good health

You may not qualify if:

  • Pregnancy
  • Intake of drugs that affect 5-HIAA excretion in urine
  • Anti-depressants
  • Participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Carcinoid TumorNeuroendocrine Tumors

Interventions

Serotonin

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TryptaminesBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Stan HM Van Uum, MD, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

May 1, 2005

Study Completion

September 1, 2005

Last Updated

April 13, 2018

Record last verified: 2006-07

Locations

CA(1)