AtherosclerosisNCT04380467
Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation
A study testing Vitamin D (cholecalciferol) in people with Atherosclerosis and Chronic Kidney Disease, run by St George's, University of London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis, Chronic Kidney Disease
- What is being tested?
- Vitamin D (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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:
- 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.
- Conditions
- Atherosclerosis, Chronic Kidney Disease
- Being tested
- Vitamin D (cholecalciferol)
- Keywords
- Vitamin D, Cholecalciferol, Chronic Kidney Disease, Cardiovascular Disease, Atherosclerosis, Flow Mediated Dilatation, Carotid Intima Media Thickness, CD4+CD28null T lymphocyte, Regulatory T lymphocyte
- Medical subject headings
- Atherosclerosis, Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (cholecalciferol)Dietary supplement
(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Group | Experimental | Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks. Receives: Dietary Supplement: Vitamin D (cholecalciferol) |
| Control | No intervention | No vitamin D given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of patients recruited from those eligible for the study.
Measured: 3 months
Retention rate
Percentage of patients recruited who completed the follow up investigations
Measured: 6 months
Acceptability to patients of randomisation procedures
Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey
Measured: 6 months
Randomisation procedure
Comparison of baseline indices of two patient groups
Measured: 6 months
Maintenance of single (observer) blinding
Incidences of unblinding of study investigator
Measured: 6 months
Adherence to vitamin D supplementation
Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels
Measured: 6 months
Secondary outcomes (3)
Witnessed change in FMD between treated and untreated subjects
Flow Mediated Dilatation
Measured: 6 months
Witnessed change in CIMT between treated and untreated subjects
Carotid Intima Media Thickness
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debasish Banarjee, Principal investigator, St Georges University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380467
- Sponsor's protocol ID
- 15.0236
- Status last verified
- May 2020
- First submitted
- 19 Jul 2016
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04380467
- Acronym / sponsor ID
- 15.0236
- Conditions
- Atherosclerosis, Chronic Kidney Disease
- Keywords
- Vitamin D, Cholecalciferol, Chronic Kidney Disease, Cardiovascular Disease, Atherosclerosis, Flow Mediated Dilatation, Carotid Intima Media Thickness, CD4+CD28null T lymphocyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Group | Experimental | Dietary Supplement: Vitamin D (cholecalciferol)Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks. |
| Control | No intervention | –No vitamin D given |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (cholecalciferol)(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks | Dietary supplement | Vitamin D Group |
Primary outcome
Recruitment rate
Time frame: 3 months
Percentage of patients recruited from those eligible for the study.
Retention rate
Time frame: 6 months
Percentage of patients recruited who completed the follow up investigations
Acceptability to patients of randomisation procedures
Time frame: 6 months
Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey
Randomisation procedure
Time frame: 6 months
Comparison of baseline indices of two patient groups
Maintenance of single (observer) blinding
Time frame: 6 months
Incidences of unblinding of study investigator
Adherence to vitamin D supplementation
Time frame: 6 months
Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels
3 secondary outcomes
Witnessed change in FMD between treated and untreated subjects
Time frame: 6 months
Witnessed change in CIMT between treated and untreated subjects
Time frame: 6 months
Witnessed change in T lymphocyte subset frequency between treated and untreated subjects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debasish Banarjee principal investigator
St Georges University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (cholecalciferol) in people with Atherosclerosis and Chronic Kidney Disease, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.