Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380467
• Other study ID #: 15.0236
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: May 2020
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• 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)

Related Conditions & MeSH terms

• Atherosclerosis
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Vitamin D (cholecalciferol)
(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks

Locations

Country	Name	City	State
United Kingdom	Debasish Banerjee	London	Tooting

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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