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

This study has been completed.

First Received on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Yale University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004654

Purpose

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.

Condition	Intervention	Phase
Hereditary Hemorrhagic Telangiectasia	Drug: soy protein isolate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: capillary malformation-arteriovenous malformation syndrome hemophilia hereditary hemorrhagic telangiectasia Parkes Weber syndrome Help Me Understand Genetics

Drug Information available for: Proteins, soy

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	60
Study Start Date:	January 1996

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004654

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Yale University

Investigators

Study Chair:

Joshua R. Korzenik

Yale University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004654 History of Changes
Other Study ID Numbers:	199/11799, YALESM-8191
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease

Additional relevant MeSH terms:

Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 09, 2012