Soy Protein Isolate vs Placebo for Hereditary Hemorrhagic Telangiectasia
soy protein isolate
Congenital Abnormalities+14
+ Cardiovascular Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: January 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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