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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
500 mcg of CI daily for 15 months
CI placebo daily for 15 months
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
Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
Time frame: Measured at Month 12
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Georgetown University Medical Center
Washington D.C., 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
...and 2 more locations