A Prospective Randomized, single centre, two arm open label trial to evaluate the efficacy of daily and weekly high dose vitamin D (Cholecalciferol) in Rheumatoid Arthritis patients – A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary aim of the study is to compare the effect of oral high dose vitamin D 60000 IU taken daily for 10 days to weekly 60000 IU dose for 10 weeks in attaining optimal level at 3 months in Vitamin D deficient (Serum 25(OH) D level of 20 ng/ml (50 nmol/L) patients of Rheumatoid Arthritis.
研究概览
简要总结
Rheumatoidarthritis (RA) is an autoimmune disorder in which unchecked immune and inflammatoryresponses cause articular pain and eventually cartilage degradation and bonedestruction . Disease develops when there is an imbalance in the cytokinenetwork, either from excess production of pro-inflammatory cytokines or frominadequate natural anti-inflammatory mechanism.VitaminD is a fat-soluble vitamin that is now known to play an important role in avariety of biologic functions including immune regulation, proliferation,differentiation, apoptosis, and angiogenesis, in addition to being the mainhormone regulating calcium phosphate homeostasis and mineral bone metabolism.It appears that vitamin Ddeficiency is highly prevalent in patients with RA, and that vitamin Ddeficiency may be linked to disease severity in RA [5,6]. Till date no studyhas evaluated the differential treatment regimens of Vitamin D in RA patients.
Baseline: Visit 1 Day 0 (when recruited and just prior to start of medicine): Demographic data, Co morbidities, tobacco use,alcohol consumption, disease duration, RF factor and Anti CCP, disease standardmedications (Methotrexate,Hydroxychlroquine, Sulphasalazine, Leflunomide and steroids),along withlab parameters (Calcium and Vitamin D).In addition, Complete blood count, Biochemical parameters (Liver and Kidneyfunction tests) results will be evaluated as routine practice. Blood samples as a part of regular follow up will be collected byclinical technicians working in Yashoda Hospitals, Secunderabad. Endof Study: Visit 2 Day 90: Labparameters: Vitamin D, Calcium, Completeblood count, Biochemical parameters (liver and kidney function tests) resultswill be evaluated. The physician will confirm if thesubject is taking the study medicine correctly, review any new medications thesubject has taken since the last visit that alters vitamin D levels and willask about adverse events that may have occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Are between the age of 18 to
- •Subjects of either gender with documented Vitamin D deficiency (Serum 25(OH) D level of <20 ng/ml (<50 nmol/L).
- •Are clinically diagnosed with RA (according to ACR 2010 criteria) (7).
- •Have active disease defined by Simplified Disease Activity Index (SDAI) >3.3(8).
排除标准
- •Hypersensitivity to cholecalciferol (Vitamin D).
- •Pregnant and lactating women.
- •History of renal or any metabolic disease.
- •Subjects having arthritis other than Rheumatoid.
- •Any illness that could impair their ability to comply with the study, or are enrolled in another study.
- •Subjects willing to stop calcium/Multivitamin supplements at the time of consent.
- •Plan to start with biological agents.
- •Mental illness impairing ability to comply with study.
结局指标
主要结局
The primary aim of the study is to compare the effect of oral high dose vitamin D 60000 IU taken daily for 10 days to weekly 60000 IU dose for 10 weeks in attaining optimal level at 3 months in Vitamin D deficient (Serum 25(OH) D level of 20 ng/ml (50 nmol/L) patients of Rheumatoid Arthritis.
时间窗: At Day 0 i.e Baseline and | At Day 90 i.e End of Study
次要结局
- To see effect of vitamin D supplementation on disease severity as assessed by Simplified Disease Activity Index (SDAI).(90 days)