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

Phase 2CompletedNCT00391924

UMC Utrecht120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Lupus Erythematosus, Systemic Sjogren's Syndrome

Interventions

DehydroepiandrosteroneDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Medical Center Groningen

Groningen, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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