Trials / Completed
CompletedNCT00004654
Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | soy protein isolate |
Timeline
- Start date
- 1996-01-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004654. Inclusion in this directory is not an endorsement.