Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

January 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia

Official Title ^ICMJE

Brief Summary

OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia.

II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. One group of patients is treated with soy protein isolate for 12 weeks. The control group receives a placebo for 12 weeks.

Patients cross to the alternate group following a 4-week washout.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Placebo Control, Crossover Assignment

Condition ^ICMJE

Hereditary Hemorrhagic Telangiectasia

Intervention ^ICMJE

Drug: soy protein isolate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following:
First-degree relative with HHT
History of recurrent epistaxis or gastrointestinal bleeding
Three or more skin telangiectasia
Migraine headache meeting International Headache Society criteria 3 or more times a month for more than 1 year
No pattern of daily headaches
No severe head trauma
No onset of headaches after 50 years of age
At least 1 month since migraine prophylaxis
At least 1 month since any of the following medications: Beta blockers; Calcium channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin re-uptake inhibitors
Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed
Creatinine no greater than 2.5 g/dL
No allergy to soy
No pregnant women
No women with intent to become pregnant

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004654

Responsible Party

Study ID Numbers ^ICMJE

199/11799, YALESM-8191

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Yale University

Investigators ^ICMJE

Study Chair:

Joshua R. Korzenik

Yale University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP