Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- General fatigue
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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)
次要结局
- 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)