The Efficacy of Vitamin D3 for the Treatment of Chronic Plaque Type Psoriatic Patients With Vitamin D Deficiency and Insufficiency: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI Score)
研究概览
简要总结
The purpose of this research is to study whether vitamin D supplement can improve clinical outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.
详细描述
While psoriasis is not a lethal disease, the disease itself can impact patients' quality of life. Nowadays there are several researches on vitamin D functions. Recently review article of vitamin D deficiency by Holick MF., stated that vitamin D can play a role in decreasing the risk of osteoporosis and other chronic diseases such as malignancy, autoimmune disease, infectious disease, cardiovascular disease, and psoriasis. Moreover, vitamin D effects on keratinocyte by decreasing abnormal cell proliferation, differentiation, apoptosis and controlling immunological process via the suppression of T-cell activation, regulation of cytokine secretion patterns, induction of regulatory T-cell, modulation of T-cell proliferation and interference with T-cell apoptosis.
Thus, our objective is to look for other alternative treatment, which may have less side effects and acceptable clinical outcomes.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderately severe (PASI ≤ 10), chronic plaque type psoriasis vulgaris patient, who is a new case or has at least treatment-free period as following: 4 weeks for topical calcipotriol, topical corticosteroid or 8 weeks for systemic therapy (i.e. cyclosporine, acitretin, methotrexate) or 12 weeks for Psoralen Ultraviolet A (PUVA), phototherapy or biological treatment.
- •Age 18-year-old to 70-year-old.
- •Psoriasis vulgaris patient with vitamin D insufficiency or deficiency.
排除标准
- •Pregnancy or Lactating mother.
- •Subject with history of major gastrointestinal surgery or gastric bypass surgery.
- •Subject with history of pustular psoriasis.
- •Subject with active psoriatic arthritis.
- •Subject with prior phototherapy within the past 3 months.
- •Subject with history of hypocholesterolemia (serum cholesterol < 120 mg/dl) or primary hyperparathyroidism.
- •Subject who regularly takes vitamin D supplement exceed 3,000 iu/day and high vitamin D diet, for example cod liver oil.
- •Subject with liver disease, cystic fibrosis, Crohn's disease, celiac sprue, renal disease, pancreatic disease, and inflammatory bowel disease.
- •Subject taking following medication: corticosteroid, orlistat, rifampicin, isoniazid, ketoconazole, statin, and cholestyramine.
研究组 & 干预措施
Vitamin D
干预措施: Vitamin D3 (Dietary Supplement)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI Score)
时间窗: 12 weeks
Normal vitamin D level after replacement correlate with improved clinical outcome (PASI Score) of psoriasis vulgaris.
次要结局
- Dermatologic Life Qualify Index (DLQI)(12 weeks)