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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).
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:
The pilot study will assess feasibility of the study methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Group | Experimental | Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks. |
|
| Control | No Intervention | No vitamin D given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (cholecalciferol) | Dietary Supplement | (aviticol) 5x 20,000unit capsules administered monthly over 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Percentage of patients recruited from those eligible for the study. | 3 months |
| Retention rate | Percentage of patients recruited who completed the follow up investigations | 6 months |
| Acceptability to patients of randomisation procedures | Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey | 6 months |
| Randomisation procedure | Comparison of baseline indices of two patient groups | 6 months |
| Maintenance of single (observer) blinding | Incidences of unblinding of study investigator | 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Witnessed change in FMD between treated and untreated subjects | Flow Mediated Dilatation | 6 months |
| Witnessed change in CIMT between treated and untreated subjects | Carotid Intima Media Thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debasish Banarjee | St Georges University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Debasish Banerjee | London | Tooting | sw17 0QT | United Kingdom |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 6 months |
| 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 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |