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OpenTrials
Completed

NCT Number: NCT00004654

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

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.

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Key information

Conditions

Hereditary Hemorrhagic Telangiectasia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

soy protein isolate

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

  • Yale University

Registry information

Important dates

Study start
1996
First posted
Feb 25, 2000
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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