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

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT00391924

Collaborator

University Medical Center Groningen (Other), Dutch Arthritis Association (Industry)

120

Enrollment

Locations

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic Sjogren's Syndrome	Drug: Dehydroepiandrosterone	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

May 1, 2000

Study Completion Date :

Jan 1, 2003

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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