Chronic Kidney DiseasePhase 4NCT00882401
Vitamin D, Chronic Kidney Disease (CKD) and the Microcirculation
A Phase 4 study testing Ergocalciferol (Vitamin D) in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Vitamin D Deficiency
- What is being tested?
- Ergocalciferol (Vitamin D)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Oct 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- eGFR between 15 and 60 ml/min/1.73m2
- Serum 25 (OH) vitamin D levels <30nmol/L
- No evidence of diabetes mellitus (fasting blood sugar <7.1, not taking any diabetic medication)
- Not receiving haemo or peritoneal dialysis
- No dialysis therapy within the last 3 months
- Age > 18 years and < 80 years
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- Patient agrees not use any medications (prescribed or over-the-counter including herbal remedies) judged to be clinically significant by the Principal Investigator during the course of the study.
- Able to understand and sign the written Informed Consent Form.
- Able and willing to follow the Protocol requirements.
Who cannot join
- Currently receiving oral ergocalciferol at any dose
- Received IM ergocalciferol therapy within last 3 months
- Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months)
- Pacemaker or any other implanted cardiac device
- Serum calcium above 2.6 mmol/L at screening
- Pregnant or lactating
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- Known hypersensitivity to ergocalciferol
- Patient known to have a condition which predisposes to hypercalcaemia (multiple myeloma, sarcoidosis, other granulomatous disease)
- Initial blood pressure of >160/100 mmHg
- History of significant liver disease or cirrhosis
- Anticipated requirement for dialysis in 6 months
- Malabsorption, severe chronic diarrhea, or ileostomy
- Known diagnosis of hypervitaminosis D
- Known to have diabetes mellitus
- Known to have renal calculi
- Known to have systemic sclerosis, Raynaud's phenomenon or other disease associated with known microcirculatory dysfunction
- Concurrent participation in any other research study
- Unwilling or unable to complete study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D on the Microcirculation of Patients With Chronic Kidney Disease (CKD) and Vitamin D Deficiency
Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and vitamin D deficiency.
Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will improve endothelial, and therefore microcirculatory function, reduce levels of oxidative stress and thus reduce the risk of future CVS events in this population.
Read the detailed description
Research rationale: Cardiovascular (CVS) diseases are the major cause of death in patients with chronic kidney disease (CKD), accounting for approximately half of all deaths. Patients with CKD are far more likely to die of CVS disease than progress to end stage renal disease. Recently, vitamin D deficiency has been identified as a non-traditional CVS risk factor. However, vitamin D is not routinely prescribed in the early stages of CKD.
Previous publications have established that endothelial, and therefore, microcirculatory dysfunction is a marker of CVS health and a predictor of future CVS events. Studies have also shown that clinical assessments of the microcirculation reflect the overall health and function of the endothelium. Vitamin D has been shown to improve endothelial function in diabetic patients with vitamin D deficiency and normal kidney function. However, no study has examined endothelial dysfunction in patients with CKD and vitamin D deficiency.
With the prevalence of CKD and concomitant vitamin D deficiency increasing worldwide, there is a pressing need to examine the effects of vitamin D therapy in the early stages of CKD. This study involves the use of four, non-invasive, detailed assessments of the microcirculation which could be used in a clinical setting to enhance CVS risk profiling. The current study design includes novel clinical and in vitro work examining endothelial function, oxidative stress levels and potential cellular mechanisms by which vitamin D improves endothelial function. Early detection of endothelial dysfunction, before end stage renal disease is reached, will provide a powerful tool for predicting future CVS events and thus provide an opportunity to intervene with therapies, including vitamin D, at an early stage of renal dysfunction.
Study objectives: Primary study objective - to evaluate the effects of vitamin D therapy on endothelial function in patients with CKD and vitamin D deficiency. Secondary study objective: to evaluate the effects of vitamin D therapy on key clinical parameters in patients with CKD and vitamin D deficiency.
Research plan: We will conduct a double blind, randomised control trial comparing oral ergocalciferol to a placebo in adult, non-diabetic patients with CKD stages 3-4 and vitamin D deficiency (defined as < 10ng/ml (<30nmol/L)). Based on power calculations, 40 subjects will be recruited in each arm as well as 15 healthy control subjects. Subjects will be followed for 7 months in total.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Being tested
- Ergocalciferol (Vitamin D), Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol (Vitamin D)Drug
Also called Drisdol
ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.
PlaceboDrug
Matching placebo at same dose schedule as ergocalciferol
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol (oral) | Active comparator | ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months. Receives: Drug: Ergocalciferol (Vitamin D) |
| Placebo | Placebo comparator | Matching placebo at same dose schedule as ergocalciferol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microcirculatory function - iontophoresis
Measured: 6 months
Secondary outcomes (1)
Key clinical parameters of CKD management
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 posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Magdi Yaqoob, MB ChB, Study chair, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882401
- Sponsor's protocol ID
- 2008-008745-38
- Other IDs
- EUDRACT number 2008-008745-38, 2008
- Status last verified
- Mar 2011
- First submitted
- 15 Apr 2009
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dreyer G, Tucker AT, Harwood SM, Pearse RM, Raftery MJ, Yaqoob MM. Ergocalciferol and microcirculatory function in chronic kidney disease and concomitant vitamin d deficiency: an exploratory, double blind, randomised controlled trial. PLoS One. 2014 Jul 9;9(7):e99461. doi: 10.1371/journal.pone.0099461. eCollection 2014.
PubMed 25006678
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on the Microcirculation of Patients With Chronic Kidney Disease (CKD) and Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT00882401
- Acronym / sponsor ID
- 2008-008745-38
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Apr 2009 (estimated)
- 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.
Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and vitamin D deficiency.
Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will improve endothelial, and therefore microcirculatory function, reduce levels of oxidative stress and thus reduce the risk of future CVS events in this population.
Detailed description
Research rationale: Cardiovascular (CVS) diseases are the major cause of death in patients with chronic kidney disease (CKD), accounting for approximately half of all deaths. Patients with CKD are far more likely to die of CVS disease than progress to end stage renal disease. Recently, vitamin D deficiency has been identified as a non-traditional CVS risk factor. However, vitamin D is not routinely prescribed in the early stages of CKD.
Previous publications have established that endothelial, and therefore, microcirculatory dysfunction is a marker of CVS health and a predictor of future CVS events. Studies have also shown that clinical assessments of the microcirculation reflect the overall health and function of the endothelium. Vitamin D has been shown to improve endothelial function in diabetic patients with vitamin D deficiency and normal kidney function. However, no study has examined endothelial dysfunction in patients with CKD and vitamin D deficiency.
With the prevalence of CKD and concomitant vitamin D deficiency increasing worldwide, there is a pressing need to examine the effects of vitamin D therapy in the early stages of CKD. This study involves the use of four, non-invasive, detailed assessments of the microcirculation which could be used in a clinical setting to enhance CVS risk profiling. The current study design includes novel clinical and in vitro work examining endothelial function, oxidative stress levels and potential cellular mechanisms by which vitamin D improves endothelial function. Early detection of endothelial dysfunction, before end stage renal disease is reached, will provide a powerful tool for predicting future CVS events and thus provide an opportunity to intervene with therapies, including vitamin D, at an early stage of renal dysfunction.
Study objectives: Primary study objective - to evaluate the effects of vitamin D therapy on endothelial function in patients with CKD and vitamin D deficiency. Secondary study objective: to evaluate the effects of vitamin D therapy on key clinical parameters in patients with CKD and vitamin D deficiency.
Research plan: We will conduct a double blind, randomised control trial comparing oral ergocalciferol to a placebo in adult, non-diabetic patients with CKD stages 3-4 and vitamin D deficiency (defined as < 10ng/ml (<30nmol/L)). Based on power calculations, 40 subjects will be recruited in each arm as well as 15 healthy control subjects. Subjects will be followed for 7 months in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol (oral) | Active comparator | Drug: Ergocalciferol (Vitamin D)ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo at same dose schedule as ergocalciferol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- eGFR between 15 and 60 ml/min/1.73m2
- Serum 25 (OH) vitamin D levels <30nmol/L
- No evidence of diabetes mellitus (fasting blood sugar <7.1, not taking any diabetic medication)
- Not receiving haemo or peritoneal dialysis
- No dialysis therapy within the last 3 months
Key exclusion criteria (18 listed)
- Currently receiving oral ergocalciferol at any dose
- Received IM ergocalciferol therapy within last 3 months
- Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months)
- Pacemaker or any other implanted cardiac device
- Serum calcium above 2.6 mmol/L at screening
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 |
|---|---|---|
| Ergocalciferol (Vitamin D)Also: Drisdolergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months. | Drug | Ergocalciferol (oral) |
| PlaceboMatching placebo at same dose schedule as ergocalciferol | Drug | Placebo |
Primary outcome
Microcirculatory function - iontophoresis
Time frame: 6 months
1 secondary outcome
Key clinical parameters of CKD management
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 22 Mar 2011.
- Derived from this study: PubMed 25006678Dreyer G, Tucker AT, Harwood SM, Pearse RM, Raftery MJ, Yaqoob MM. Ergocalciferol and microcirculatory function in chronic kidney disease and concomitant vitamin d deficiency: an exploratory, double blind, randomised controlled trial. PLoS One. 2014 Jul 9;9(7):e99461. doi: 10.1371/journal.pone.0099461. eCollection 2014.
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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.
Magdi Yaqoob, MB ChB study chair
Barts and the London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol (Vitamin D) in people with Chronic Kidney Disease and Vitamin D Deficiency, run by Barts & The London NHS Trust 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 9 inclusion and 18 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 22 Mar 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Microcirculatory function - iontophoresis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00882401, which also lists 1 linked publication.
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 22 Mar 2011.