Hereditary Hemorrhagic Telangiectasia
Conditions
Keywords
genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease
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.
Interventions
Sponsors
Yale University
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion 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
Outcome results
None listed