Lupus Erythematosus, Systemic, Sjogren's Syndrome
Conditions
Keywords
Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density
Brief summary
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
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.
Interventions
DRUGDehydroepiandrosterone
Sponsors
University Medical Center Groningen
Dutch Arthritis Association
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
| General fatigue | — |
| Depressive mood | — |
| Mental well-being | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported pain, | — |
| Fibromyalgia tender points | — |
| Self-reported oral dryness (in pSS only) | — |
| Hemoglobin | — |
| Serum Immunoglobulin-G | — |
| Self-reported ocular dryness (in pSS only) | — |
| Erythrocyte sedimentation rate | — |
| 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) | — |
Countries
Netherlands
Outcome results
None listed