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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Yale University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004654 |
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 |
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Hereditary Hemorrhagic Telangiectasia |
Drug: soy protein isolate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control, Crossover Assignment |
Estimated Enrollment: | 60 |
Study Start Date: | January 1996 |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 199/11799, YALESM-8191 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004654 History of Changes |
Health Authority: | United States: Federal Government |
genetic diseases and dysmorphic syndromes hematologic disorders hereditary hemorrhagic telangiectasia rare disease |
Hemorrhagic Disorders Cardiovascular Abnormalities Hematologic Diseases Telangiectasia, Hereditary Hemorrhagic Blood Coagulation Disorders Vascular Malformations |
Telangiectasis Vascular Diseases Rare Diseases Hereditary Hemorrhagic Telangiectasia Congenital Abnormalities Hemostatic Disorders |
Hemorrhagic Disorders Cardiovascular Abnormalities Hematologic Diseases Telangiectasia, Hereditary Hemorrhagic Vascular Malformations |
Telangiectasis Vascular Diseases Cardiovascular Diseases Congenital Abnormalities Hemostatic Disorders |