NCT00005675

Oral Type I Collagen for Relieving Scleroderma

Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scleroderma
• Connective Tissue Diseases

Interventions

Type	Name	Description
DRUG	Oral bovine type I collagen	500 mcg of CI daily for 15 months
DRUG	Placebo	CI placebo daily for 15 months

Timeline

• Start date: 2000-04-01
• Primary completion: 2005-05-01
• First posted: 2000-05-29
• Last updated: 2010-05-25

Locations

12 sites across 1 country: United States