Evaluation of Vitamin D Levels in Psoriasis Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The relationship between level of vitamin D and psoriasis severity
研究概览
简要总结
The purpose of this research study is to find out more about the relationship between vitamin D and psoriasis.
详细描述
Study Design Subjects will be recruited from an outpatient population of subjects with psoriasis from Dr. Jennifer Soung's clinic at the Gottschalk Medical Plaza at the University of California, Irvine. Subjects with the requisite diagnosis of psoriasis who are starting a new form of therapy will be candidates for enrollment. Subjects who choose not to participate in the study will receive their standard of care treatment without any monitoring for vitamin D level. The protocol for this study is as follows.
Subjects will be screened and consented. Upon entry into the study, the study subject's severity of disease will be evaluated by the investigator, using the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Physician's Global Assessment (PGA). These assessments will be repeated at all future study visits.
Subjects will receive whichever standard of care treatment for their psoriasis as if they were not participating in this study. Subjects will have their disease severity evaluated and a vitamin D level drawn at Baseline (prior to initiating treatment), Week 12, Week 24, and Week 52.
Study Procedures:
All study procedures will take place at the UCI Dermatology Research Center and Institute for Clinical and Translational Research (ICTS) located at 843 Health Sciences Road, Irvine, CA 92697. The subject will be informed of his or her vitamin D level results at any time. Should the level be dangerously low (per the laboratory reference point), the subject will be treated for vitamin D deficiency as necessary per standard of care. Subjects will be categorized as starting topical therapy, phototherapy and systemic therapy, or biologic therapy. For all Vitamin D level testing in this protocol, the Vitamin D 25-hydroxy level will be drawn, which involves 0.5mL of blood per draw.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Be at least 18 years of age at time of informed consent.
- •Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris).
- •Subject is about to start a new kind of therapeutic treatment, either topical, phototherapy, systemic, or biologic agent.
排除标准
- •Subject is not over 18 years of age.
- •Subject cannot understand or follow directions.
- •Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
- •Subject is pregnant or planning to get pregnant
结局指标
主要结局
The relationship between level of vitamin D and psoriasis severity
时间窗: 52 Weeks
Subjects will have their disease severity evaluated and a vitamin D level drawn at Baseline (prior to initiating treatment), Week 12, Week 24, and Week 52.
次要结局
未报告次要终点
研究者
Natasha Mesinkovska
Lead Researcher
University of California, Irvine
