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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004654
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
  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 3

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004654


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Yale University
Investigators
Study Chair: Joshua R. Korzenik Yale University
  More Information

ClinicalTrials.gov Identifier: NCT00004654     History of Changes
Other Study ID Numbers: 199/11799
YALESM-8191
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2001

Keywords provided by Office of Rare Diseases (ORD):
genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease

Additional relevant MeSH terms:
Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities