Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia

Hereditary Hemorrhagic Telangiectasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004654
• Other study ID #: 199/11799
• Secondary ID: YALESM-8191
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: January 1996

Study information

• Verified date: December 2001
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

• 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hereditary Hemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Drug:
• soy protein isolate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Yale University