CTRI/2023/03/050766尚未招募不适用
Effect of Narrow Band Ultraviolet-B treatment on bone mineral density and vitamin D levels in vitiligo
Keshavamurthy Vinay1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Measurement of bone mineral density using dual-energy X-ray absorptiometry (DEXA) at baseline and after 24 weeks.
研究概览
简要总结
| Whole body narrow band-ultraviolet B (NB-UVB) phototherapy is widely used to treat extensive and spreading vitiligo. NB-UVB phototherapy is known to cause disease stabilization as well as re-pigmentation. Several other benefits of NB-UVB, including reduction in risk of cerebrovascular and cardiovascular adverse events have been observed. Indirect impact of NB-UVB on bone mineral density has been reported in terms of reduction in risk of osteoporotic fractures. However, direct impact of NB-UVB on bone health has not been assessed before. The present study, we aim to assess the effect of Narrow Band Ultraviolet-B treatment on bone mineral density and vitamin D levels in vitiligo patients who have previously received corticosteroid therapy. Further, as corticosteroid-induced osteopenia/osteoporosis tends to improve on cessation of steroid therapy, a control group in which patient |
| will receive a non-steroidal disease stabilising agent (e.g., azathioprine, cyclosporine, methotrexate, etc.) with no known impact on bone mineral density will also be recruited. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of non-segmental vitiligo involving 10-50% of body surface area 2.Age 12-60 years 3.Unstable disease, defined as occurrence of new lesion(s), progression of existing lesion(s) or Koebnerization 4.Should have received corticosteroids in any dose for >3 months.
排除标准
- •1.Patients of segmental vitiligo and universal vitiligo 2.Contraindication to use of NBUVB phototherapy including xeroderma pigmentosa, systemic lupus erythematosus and other photo-induced or photo-aggravated dermatoses 3.Intake of phototoxic drugs 4.History of skin malignancy, premalignant skin lesions and dysplastic naevi 5.Claustrophobia 6.Hepatic and renal dysfunction 7.Immunosuppression 8.Associated connective tissue diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis 9.Pregnancy and lactation.
结局指标
主要结局
1. Measurement of bone mineral density using dual-energy X-ray absorptiometry (DEXA) at baseline and after 24 weeks.
时间窗: Baseline | 24 weeks
2. Measurement of serum vitamin D levels at baseline and after 24 weeks
时间窗: Baseline | 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During WinterVitamin D DeficiencyNCT02275650Joint Authority for Päijät-Häme Social and Health Care37
已完成
2 期
Effect of narrow band UVB phototherapy plus betamethasone ointment versus narrow band UVB phototherapy plus placebo ointment on the treatment of vitiligoVitiligo.VitiligoIRCT201402269014N26Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences30
尚未招募
不适用
Efficacy of narrowband ultraviolet B phototherapy for patients with intractable pruritus cutaneusJPRN-UMIN000038976agoya City University30
已完成
不适用
The effect of phototherapy on serum folic acid levelAtopic dermatitis-vitiligo-psoriasis.Atopic dermatitis-vitiligo-psoriasisL20-L80-L4IRCT2015111525026N2Vice chancellor for research,Babol University of Medical Sciences30
尚未招募
Unknown
Impact of light therapy on bone strength and blood vitamin D levels in vitiligo patientsCTRI/2023/03/050766Keshavamurthy Vinay