Chronic Kidney Disease Clinical Trial
Official title:
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
NCT number | NCT04380467 |
Other study ID # | 15.0236 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | October 2016 |
Verified date | May 2020 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-80 years 2. Calcium < 2.58mmol/l 3. On an ACE inhibitor/ARB 4. Vitamin D <75nmol/l 5. eGFR 15- 60ml/min/1.73m2 and stable 6. Informed consent to participate Exclusion Criteria: 1. Patients already on Vitamin D or calcium supplementation 2. Patients with known malignancies 3. Patients with autoimmune conditions 4. Patients with heart failure (ejection fraction <40%, Plasma NT pro-BNP>500pg/ml) 5. Patients with active infection 6. Rapidly deteriorating renal function 7. Recent Acute coronary syndrome or cerebro-vascular event (within the last 6 months) 8. Uncontrolled hypertension (BP>160 systolic) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Debasish Banerjee | London | Tooting |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | Percentage of patients recruited from those eligible for the study. | 3 months | |
Primary | Retention rate | Percentage of patients recruited who completed the follow up investigations | 6 months | |
Primary | Acceptability to patients of randomisation procedures | Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey | 6 months | |
Primary | Randomisation procedure | Comparison of baseline indices of two patient groups | 6 months | |
Primary | Maintenance of single (observer) blinding | Incidences of unblinding of study investigator | 6 months | |
Primary | Adherence to vitamin D supplementation | Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels | 6 months | |
Secondary | Witnessed change in FMD between treated and untreated subjects | Flow Mediated Dilatation | 6 months | |
Secondary | Witnessed change in CIMT between treated and untreated subjects | Carotid Intima Media Thickness | 6 months | |
Secondary | Witnessed change in T lymphocyte subset frequency between treated and untreated subjects | CD4+CD28null T lymphocytes and Regulatory T cells as determined by flow cytometry of whole blood | 6 months |
Status | Clinical Trial | Phase | |
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