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Completed

NCT Number: NCT00391924

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

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

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Key information

Conditions

Lupus Erythematosus, Systemic Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Fatigue Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Salivary Gland Diseases Signs and Symptoms Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dehydroepiandrosterone

Drug

Primary outcomes

  1. General fatigue

  2. Depressive mood

  3. Mental well-being

  4. Physical functioning

  5. (all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)

Secondary outcomes

  1. Self-reported pain,

  2. Fibromyalgia tender points

  3. Erythrocyte sedimentation rate

  4. Hemoglobin

  5. Serum Immunoglobulin-G

  6. Self-reported ocular dryness (in pSS only)

  7. Self-reported oral dryness (in pSS only)

  8. Ocular tear production (in pSS only)

  9. SLE disease activity index (in SLE only)

  10. Bone mineral density (in SLE only)

  11. Dose of glucocorticoids (in SLE only)

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dutch Arthritis Association
  • University Medical Center Groningen

Registry information

Official study title

Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

Important dates

Study start
2000
Study completion
2003
First posted
Oct 25, 2006
Registry last updated
Oct 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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