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

NCT ID: NCT04380467

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-10-31

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.

Conditions

Atherosclerosis; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Vitamin D Group

Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks.

Group Type: EXPERIMENTAL

Vitamin D (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks

Control

No vitamin D given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D (cholecalciferol)

(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debasish Banarjee

Role: PRINCIPAL_INVESTIGATOR

St Georges University NHS Foundation Trust

Locations

Debasish Banerjee

London, Tooting, United Kingdom

Countries

United Kingdom

Other Identifiers

15.0236

Identifier Type: -

Identifier Source: org_study_id