Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation
- Conditions
- AtherosclerosisChronic Kidney Disease
- Interventions
- Dietary Supplement: Vitamin D (cholecalciferol)
- Registration Number
- NCT04380467
- Lead Sponsor
- St George's, University of London
- Brief Summary
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).
- Detailed Description
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:
1. Measurement of Brachial Artery Flow Mediated Dilatation
2. Measurement of Carotid Intima Media Thickness
3. Quantification of CD4+CD28null and regulatory T cell frequency
The pilot study will assess feasibility of the study methods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Group Vitamin D (cholecalciferol) Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks.
- Primary Outcome Measures
Name Time Method Retention rate 6 months Percentage of patients recruited who completed the follow up investigations
Recruitment rate 3 months Percentage of patients recruited from those eligible for the study.
Randomisation procedure 6 months Comparison of baseline indices of two patient groups
Maintenance of single (observer) blinding 6 months Incidences of unblinding of study investigator
Adherence to vitamin D supplementation 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 6 months Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey
- Secondary Outcome Measures
Name Time Method Witnessed change in FMD between treated and untreated subjects 6 months Flow Mediated Dilatation
Witnessed change in T lymphocyte subset frequency between treated and untreated subjects 6 months CD4+CD28null T lymphocytes and Regulatory T cells as determined by flow cytometry of whole blood
Witnessed change in CIMT between treated and untreated subjects 6 months Carotid Intima Media Thickness
Trial Locations
- Locations (1)
Debasish Banerjee
🇬🇧London, Tooting, United Kingdom