Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Primary Purpose
Carcinoid Tumors, Neuroendocrine Tumors
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
5-Hydroxy-Tryptamine
Sponsored by
About this trial
This is an interventional diagnostic trial for Carcinoid Tumors focused on measuring 5Hydroxytryptamine, Chromogranin A, 5HIAA, carcinoid
Eligibility Criteria
Inclusion Criteria: 18 years and older in good health Exclusion Criteria: Pregnancy Intake of drugs that affect 5-HIAA excretion in urine Anti-depressants Participation in other studies
Sites / Locations
- St. Joseph's Health Care
Outcomes
Primary Outcome Measures
Urinary excretion of 5-HIAA
Plasma Chromogranin A
Secondary Outcome Measures
Side effects
Full Information
NCT ID
NCT00227136
First Posted
September 23, 2005
Last Updated
April 11, 2018
Sponsor
University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00227136
Brief Title
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Official Title
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Terminated
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Western Ontario, Canada
4. Oversight
5. Study Description
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.
Detailed Description
5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. It is claimed to improve sleep problems, depression, anxiety, compulsive disorders, restless leg syndrome, migraines, fibromyalgia, and low pain threshold.Increased levels of 5-HIAA in the urine can be a of a specific type of cancer, called carcinoid tumor. Urinary 5-HIAA levels can also be increased by a number of food products and drugs. Oral 5-HTP is not known as a cause of elevation of 5-HIAA in urine. However, recent information suggests that 5-HTP may cause an increase.
In this study we examine the effect of oral 5-HTP intake (100 mg at bedtime for 10 days) on 5-HIAA excretion in the urine, following a prospective, double-blind placebo-controlled study design.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Tumors, Neuroendocrine Tumors
Keywords
5Hydroxytryptamine, Chromogranin A, 5HIAA, carcinoid
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
5-Hydroxy-Tryptamine
Primary Outcome Measure Information:
Title
Urinary excretion of 5-HIAA
Title
Plasma Chromogranin A
Secondary Outcome Measure Information:
Title
Side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older
in good health
Exclusion Criteria:
Pregnancy
Intake of drugs that affect 5-HIAA excretion in urine
Anti-depressants
Participation in other studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan HM Van Uum, MD, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
12. IPD Sharing Statement
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Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
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