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

St George's, University of London

Status: Completed

Conditions: Chronic Kidney Disease; Atherosclerosis

Treatments: Dietary Supplement: Vitamin D (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04380467

15.0236

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Vitamin D Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D (cholecalciferol)

Control

No Intervention group

Description:

No vitamin D given