Impact of Vitamin D Supplementation on Vascular Function, Vascular Structure and Immune Regulation in Patients With Chronic Kidney Disease and Low Vitamin D Levels - A Pilot Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
A pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery), vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).
详细描述
The study is a single (observer) blinded feasibility pilot randomised study. Study subjects will be recruited from clinics run by St George's Hospital Renal Department and randomised to treatment arm or no treatment arm.
In treatment arm, six doses of vitamin D tablets (cholecalciferol 100,000 IU, five capsules total) will be administered on weeks 0, 4, 8, 12, 16 and 20. In the no-treatment arm the participants receive no cholecalciferol. Participants will have serum calcium levels measured at week 12.
All participants will undergo estimation of endothelial function, carotid intima-media thickness, CD4+CD28null and regulatory T cell frequency in week 0 and week 26. The observer will be blinded to whether the patient is in the treatment or no-treatment arm whilst the following tests are performed:
- Measurement of Brachial Artery Flow Mediated Dilatation
- Measurement of Carotid Intima Media Thickness
- Quantification of CD4+CD28null and regulatory T cell frequency
The pilot study will assess feasibility of the study methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Calcium < 2.58mmol/l
- •On an ACE inhibitor/ARB
- •Vitamin D <75nmol/l
- •eGFR 15- 60ml/min/1.73m2 and stable
- •Informed consent to participate
排除标准
- •Patients already on Vitamin D or calcium supplementation
- •Patients with known malignancies
- •Patients with autoimmune conditions
- •Patients with heart failure (ejection fraction <40%, Plasma NT pro-BNP>500pg/ml)
- •Patients with active infection
- •Rapidly deteriorating renal function
- •Recent Acute coronary syndrome or cerebro-vascular event (within the last 6 months)
- •Uncontrolled hypertension (BP>160 systolic)
研究组 & 干预措施
Vitamin D Group
Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks.
干预措施: Vitamin D (cholecalciferol) (Dietary Supplement)
Control
No vitamin D given
结局指标
主要结局
Retention rate
时间窗: 6 months
Percentage of patients recruited who completed the follow up investigations
Recruitment rate
时间窗: 3 months
Percentage of patients recruited from those eligible for the study.
Randomisation procedure
时间窗: 6 months
Comparison of baseline indices of two patient groups
Maintenance of single (observer) blinding
时间窗: 6 months
Incidences of unblinding of study investigator
Adherence to vitamin D supplementation
时间窗: 6 months
Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels
Acceptability to patients of randomisation procedures
时间窗: 6 months
Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey
次要结局
- Witnessed change in FMD between treated and untreated subjects(6 months)
- Witnessed change in T lymphocyte subset frequency between treated and untreated subjects(6 months)
- Witnessed change in CIMT between treated and untreated subjects(6 months)