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CompletedNCT00005675Updated May 25, 2010

Oral Type I Collagen for Relieving Scleroderma

A Phase 2 interventional study of Oral bovine type I collagen and Placebo in Scleroderma and Connective Tissue Diseases, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-25.

Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Scleroderma
  • Connective Tissue Diseases

Keywords

  • Systemic Scleroderma (SSc)
  • Bovine Type I Collagen (CI)
  • Multicenter
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In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's enrollment of 168 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    1

    Participants will receive oral bovine type I collagen (CI) daily for 15 months

    Drug: Oral bovine type I collagen

  • Placebo comparator
    2

    Participants will receive placebo daily for 15 months.

    Drug: Placebo

Interventions

  • DrugOral bovine type I collagen

    500 mcg of CI daily for 15 months

    Also known as: CI

  • DrugPlacebo

    CI placebo daily for 15 months

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What researchers measure

Primary outcomes

  1. 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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Study locations

12 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • University of California Los Angeles
    Los Angeles, California 90024, United States
  • University of Connecticut
    Farmington, Connecticut 06030-1310, United States
  • Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
  • Boston University School Of Medicine
    Boston, Massachusetts 02188, United States
  • Wayne State University
    Detroit, Michigan 48201, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Tennessee Health Science Center
    Memphis, Tennessee 38163, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Virginia Mason Research Center
    Seattle, Washington 98101, United States
08

References and documents

Publications

  • Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z. PubMed 11177772 ↗
  • Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. doi: 10.1002/art.20361. No abstract available. PubMed 15334493 ↗
  • Postlethwaite AE, Wong WK, Clements P, Chatterjee S, Fessler BJ, Kang AH, Korn J, Mayes M, Merkel PA, Molitor JA, Moreland L, Rothfield N, Simms RW, Smith EA, Spiera R, Steen V, Warrington K, White B, Wigley F, Furst DE. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum. 2008 Jun;58(6):1810-22. doi: 10.1002/art.23501. PubMed 18512816 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005675
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators
Wayne State University, University of California, Los Angeles, UTHSC, Medical University of South Carolina, Beth Israel Medical Center, University of Alabama at Birmingham, Johns Hopkins University, Georgetown University, Baltimore VA Medical Center, Northwestern University
First posted
May 29, 2000
Start date
Apr 2000
Primary completion
May 2005
Last update
May 25, 2010

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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