Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004654
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Placebo-Controlled Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Patients cross to the alternate group following a 4-week washout
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| YALESM-8191 | None | None | None |