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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Lupus Erythematosus, Systemic, Sjogren's Syndrome

Intervention / Treatment
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* Drug: Dehydroepiandrosterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dehydroepiandrosterone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density