NCT00418587已完成1 期
Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Hypercalcuria
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE by ACR criteria (revised 1997)
- •African American, participating in the SLE in Gullah Health (SLEIGH) Study
- •Outpatient
- •Stable disease with no BILAG A or B in any system for the past 4 weeks
- •Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
- •Baseline 25(OH)D concentration of < 30 ng/ml
- •Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
- •Age 18 - 85 years
- •Ability to complete questionnaires in English
- •Ability to give informed consent
排除标准
- •Presence of hypercalcemia (>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
- •Liver disease (serum ALT, AST >2x normal) or total serum bilirubin >1.5x normal
- •History of renal stones
- •Current treatment with any dose of cyclophosphamide
- •Dialysis or creatinine > 2.5 mg/dL
- •Pregnancy
- •Current drug or alcohol abuse
- •Anticipated poor compliance
研究组 & 干预措施
1
Experimental
800 IU oral daily dose level
干预措施: Cholecalciferol (Drug)
2
Experimental
2000 IU oral daily dose level
干预措施: Cholecalciferol (Drug)
3
Experimental
4000 IU oral daily dose level
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Hypercalcuria
时间窗: Monthly
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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