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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:
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004654
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  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:

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 May 23, 2013