NCT04380467

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D (cholecalciferol)	(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2020-05-08
• Last updated: 2020-05-08

Locations

1 site across 1 country: United Kingdom