Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD) (5C)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by St George's, University of London.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
St George's, University of London
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
St George's, University of London
ClinicalTrials.gov Identifier:
NCT01323712
First received: March 25, 2011
Last updated: December 6, 2013
Last verified: December 2013
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Purpose
Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is very common in CKD and associated with CVD. Animal studies have shown an improvement in heart size and function with Vitamin D therapy, although evidence in humans is lacking. The proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve heart enlargement and function. With these proposed changes the investigators expect to reduce CVD and deaths in patients with CKD.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Dietary Supplement: Vitamin D Cholecalciferol |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Impact of Vitamin D Supplementation on Cardiac Hypertrophy and Function in Chronic Kidney Disease Patients - a Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by St George's, University of London:
Primary Outcome Measures:
- Left ventricular mass [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cardiac systolic and diastolic function [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Dietary Supplement: Vitamin D Cholecalciferol
Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 50 adult (18-75 years old)
- patients with estimated GFR between 15-45 ml/min/1.73 m2 (CKD stage 3b and 4) on ACE inhibitors and/or ARB therapy will be recruited.
Exclusion Criteria:
The following patients will be excluded from the trial:
- patients with diabetes mellitus
- Hb < 10gm% or on EPO
- serum calcium > 2.55 mmol/L
- known malignancies
- patients on vitamin D supplementation
- heart failure (ejection fraction < 40 or pro NT BNP > 500 pg/ml
- uncontrolled hypertension (BP > 150/90 mmHg)
- patients with AV fistula for dialysis access
- significant valvular heart disease
- conditions that may influence collagen metabolism such as recent (< 6months) surgery or trauma
- fibrotic diseases or active inflammatory conditions
- history of myocardial infarction and/or Troponin T > 0.5
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01323712
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323712
Locations
| United Kingdom | |
| Debasish Banerjee | |
| London, Tooting, United Kingdom, sw17 0QT | |
| Guy's and St Thomas' NHS Foundation Trust | |
| London, United Kingdom | |
Sponsors and Collaborators
St George's, University of London
Guy's and St Thomas' NHS Foundation Trust
Investigators
| Principal Investigator: | Debasish Banerjee, MD FRCP | St George's, University of London |
More Information
| Responsible Party: | St George's, University of London |
| ClinicalTrials.gov Identifier: | NCT01323712 History of Changes |
| Other Study ID Numbers: | BHF PG/10/71/28462 PG/10/71/28462 |
| Study First Received: | March 25, 2011 |
| Last Updated: | December 6, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by St George's, University of London:
|
CKD LV mass Vitamin D LV function |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Hypertrophy Cardiomegaly Urologic Diseases Renal Insufficiency Pathological Conditions, Anatomical Heart Diseases Cardiovascular Diseases |
Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 23, 2016