Phase III Randomized, Placebo-Controlled, Crossover Study... | NCT00004654

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

NCT00004654

Sponsor

National Center for Research Resources (NCRR)

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 3

Conditions

Hereditary Hemorrhagic Telangiectasia

Interventions

soy protein isolate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
YALESM-8191

Status Module

Record Verification Date

Dec 2001

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1996

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 24, 2000

First Submission Date that Met QC Criteria

Feb 24, 2000

First Posted Date

Feb 25, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Yale University	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
soy protein isolate	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Joshua R. Korzenik	Yale University	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D013683	Telangiectasia, Hereditary Hemorrhagic
D030342	Genetic Diseases, Inborn
D006402	Hematologic Diseases
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013684	Telangiectasis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D030262	Soybean Proteins

Ancestor Terms

ID	Term
D010940	Plant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014674	Plant Proteins, Dietary

Browse Leaves

Not provided

Browse Branches

Not provided