Oral Type I Collagen for Relieving Scleroderma
- Conditions
- SclerodermaConnective Tissue Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT00005675
- Lead Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Brief Summary
Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.
- Detailed Description
SSc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. This study will determine if a daily oral dose of bovine CI will improve the condition of patients with SSc.
Patients will be randomly assigned to one of two groups. The first group will receive 500 mcg bovine CI daily for 15 months; the second group will receive placebo. Study visits will be conducted at Months 4, 8, 12, and 15. Patients will undergo physical examination and blood tests at each visit. Patients will also be evaluated for modified Rodnan skin score (MRSS) and will be given health assessment questionnaires. A chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and Month 12.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less
- Stable skin involvement by history or physical examination 6 months prior to study entry
- Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry
- Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit
- Agree to use acceptable forms of contraception
- Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry
- Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
- Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin
- Limited and localized (morphea) or linear SSc
- Tenderness or swelling of the extremities (eosinophilic fasciitis)
- Pregnancy
- Use of certain medications
- Allergy to beef or dairy products
- Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.
- Use of herbal and some alternative therapies
- Any organ transplant or stem cell transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Oral bovine type I collagen Participants will receive oral bovine type I collagen (CI) daily for 15 months 2 Placebo Participants will receive placebo daily for 15 months.
- Primary Outcome Measures
Name Time Method Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests Measured at Month 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of Connecticut
🇺🇸Farmington, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Boston University School Of Medicine
🇺🇸Boston, Massachusetts, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Scroll for more (2 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States