Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

This study has been completed.
Sponsor:
Collaborators:
University Medical Centre Groningen
Dutch Arthritis Association
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00391924
First received: October 24, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome


Condition Intervention Phase
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Drug: Dehydroepiandrosterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • General fatigue
  • Depressive mood
  • Mental well-being
  • Physical functioning
  • (all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)

Secondary Outcome Measures:
  • Self-reported pain,
  • Fibromyalgia tender points
  • Erythrocyte sedimentation rate
  • Hemoglobin
  • Serum Immunoglobulin-G
  • Self-reported ocular dryness (in pSS only)
  • Self-reported oral dryness (in pSS only)
  • Ocular tear production (in pSS only)
  • SLE disease activity index (in SLE only)
  • Bone mineral density (in SLE only)
  • Dose of glucocorticoids (in SLE only)

Estimated Enrollment: 120
Study Start Date: May 2000
Estimated Study Completion Date: January 2003
Detailed Description:

Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pSS with a focus score >= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)
  • SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)
  • Willingness to apply effective contraception (premenopausal women)
  • Written informed consent.

Exclusion Criteria:

  • Pregnancy
  • Pregnancy wish
  • Serum creatinine > 150 µmol/L
  • Glucocorticoid use at a daily dose > 10 mg prednisone (or equivalent)
  • Cyclophosphamide treatment in the preceding year
  • Hyper- or hypothyroidism
  • History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391924

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA
Sponsors and Collaborators
UMC Utrecht
University Medical Centre Groningen
Dutch Arthritis Association
Investigators
Study Chair: Ronald HW Derksen, MD,PhD UMC Utrecht
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00391924     History of Changes
Other Study ID Numbers: NR 98-2-301
Study First Received: October 24, 2006
Last Updated: October 24, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Dehydroepiandrosterone
Fatigue
Quality of life
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Bone mineral density

Additional relevant MeSH terms:
Sjogren's Syndrome
Syndrome
Lupus Erythematosus, Systemic
Disease
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014