Trial | NCT04380467  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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:

Measurement of Brachial Artery Flow Mediated Dilatation
Measurement of Carotid Intima Media Thickness
Quantification of CD4+CD28null and regulatory T cell frequency

The pilot study will assess feasibility of the study methods.
Study Started
Jan 31
2016
Primary Completion
Oct 31
2016
Study Completion
Oct 31
2016
Last Update
May 08
2020

Dietary Supplement Vitamin D (cholecalciferol)

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

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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)
No Results Posted