- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004654
Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Joshua R. Korzenik, Yale University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11799
- YALESM-8191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Hemorrhagic Telangiectasia
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Vaderis Therapeutics AGRecruitingHereditary Hemorrhagic Telangiectasia (HHT)United States, Spain, France, Belgium, Netherlands, Italy
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Unity Health TorontoSunnybrook Health Sciences Centre; University of Pittsburgh; Duke University; Barrow... and other collaboratorsActive, not recruitingHereditary Hemorrhagic Telangiectasia (HHT)Canada
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Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia (HHT)United Kingdom
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University Hospital, EssenCompletedHereditary Haemorrhagic Telangiectasia (HHT)Germany
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University of PennsylvaniaCompletedHereditary Hemorrhagic Telangiectasia (HHT)United States
-
University Hospital, EssenCompleted
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Centre Hospitalier Universitaire DijonCompletedHereditary Hemorrhagic TelangiectasiaFrance
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Hospices Civils de LyonCompletedHHT | Hemorrhagic Hereditary TelangiectasiaFrance
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Unity Health TorontoThe Hospital for Sick Children; Sunnybrook Health Sciences Centre; National Institute... and other collaboratorsCompletedHereditary Hemorrhagic TelangiectasiaCanada
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedHereditary Hemorrhagic TelangiectasiaItaly
Clinical Trials on soy protein isolate
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
University of FloridaCompletedRenal Failure | Chronic Kidney Disease Requiring Chronic DialysisUnited States
-
University of Illinois at ChicagoNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Mette HansenAker Biomarine Antarctic ASCompletedHuman NutritionDenmark
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)TerminatedBreast CancerUnited States
-
University of TorontoDairy Management Inc.RecruitingDietary ProteinsCanada
-
Jill Hamilton-Reeves, PhD RD LDSoy Nutrition InstituteWithdrawnCardiovascular Disease | Subclinical HypothyroidUnited States
-
Maastricht University Medical CenterEuropean Dairy Association (EDA), BrusselsCompletedChronic Obstructive Pulmonary DiseaseNetherlands
-
Chulalongkorn UniversityNot yet recruiting