Oral Type I Collagen for Relieving Scleroderma

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.

Conditions

• Scleroderma
• Connective Tissue Diseases

Interventions

DRUG

Oral bovine type I collagen

500 mcg of CI daily for 15 months

DRUG

Placebo

CI placebo daily for 15 months

Sponsors & Collaborators

• Wayne State University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• UTHSC

  collaborator UNKNOWN

• Medical University of South Carolina

  collaborator OTHER

• Beth Israel Medical Center

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• Baltimore VA Medical Center

  collaborator FED

• Northwestern University

  collaborator OTHER

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  lead NIH

Principal Investigators

• Arnold E. Postlethwaite, MD · University of Tennessee at Memphis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-04-30

Primary Completion

2005-05-31

Countries

• United States

Study Locations