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

Primary Purpose

Hereditary Hemorrhagic Telangiectasia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
soy protein isolate
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Hemorrhagic Telangiectasia focused on measuring genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004654
    Brief Title
    Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Yale University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hereditary Hemorrhagic Telangiectasia
    Keywords
    genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Allocation
    Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    soy protein isolate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua R. Korzenik
    Organizational Affiliation
    Yale University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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