Clinical trial NCT00391924: Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
Official title: Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Sjogren's Syndrome
Keywords: Dehydroepiandrosterone
Fatigue
Quality of life
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Bone mineral density
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Dutch Arthritis Association
First posted: 2006-10-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: General fatigue
measure: Depressive mood
measure: Mental well-being
measure: Physical functioning
measure: (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:
measure: Self-reported pain,
measure: Fibromyalgia tender points
measure: Erythrocyte sedimentation rate
measure: Hemoglobin
measure: Serum Immunoglobulin-G
measure: Self-reported ocular dryness (in pSS only)
measure: Self-reported oral dryness (in pSS only)
measure: Ocular tear production (in pSS only)
measure: SLE disease activity index (in SLE only)
measure: Bone mineral density (in SLE only)
measure: Dose of glucocorticoids (in SLE only)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Ronald HW Derksen, MD,PhD
role: STUDY_CHAIR
References:
citation: Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. The effect of dehydroepiandrosterone on lumbar spine bone mineral density in patients with quiescent systemic lupus erythematosus. Arthritis Rheum. 2004 Nov;50(11):3591-5. doi: 10.1002/art.20610.
citation: Hartkamp A, Geenen R, Bijl M, Kruize AA, Godaert GL, Derksen RH. Serum cytokine levels related to multiple dimensions of fatigue in patients with primary Sjogren's syndrome. Ann Rheum Dis. 2004 Oct;63(10):1335-7. doi: 10.1136/ard.2003.011825.
citation: Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial. Ann Rheum Dis. 2010 Jun;69(6):1144-7. doi: 10.1136/ard.2009.117036. Epub 2009 Oct 22.