- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00882401
Vitamin D, Chronic Kidney Disease (CKD) and the Microcirculation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, E1 1BB
- Barts and the London NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ergocalciferol (oral)
ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.
|
ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.
Other Names:
|
Placebo Comparator: Placebo
Matching placebo at same dose schedule as ergocalciferol
|
Matching placebo at same dose schedule as ergocalciferol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microcirculatory function - iontophoresis
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Key clinical parameters of CKD management
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Magdi Yaqoob, MB ChB, Barts and the London NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Kidney Diseases
- Renal Insufficiency, Chronic
- Vitamin D Deficiency
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Ergocalciferols
Other Study ID Numbers
- 2008-008745-38
- EUDRACT number 2008-008745-38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
University Hospital, Clermont-FerrandTerminated
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
Clinical Trials on Ergocalciferol (Vitamin D)
-
Brigham and Women's HospitalWithdrawnNephrolithiasis | Vitamin D DeficiencyUnited States
-
University of North Carolina, Chapel HillNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
-
Boston UniversityCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
NYU Langone HealthCompletedVitamin D DeficiencyUnited States
-
University of KansasCompletedEnd-Stage Renal Disease
-
Massachusetts General HospitalCompleted
-
Brigham and Women's HospitalTerminatedPain | Fractures, Bone | Muscle Weakness | Kidney Disease
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of Wisconsin, MadisonMayday FundTerminated