Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD) (5C)
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| ClinicalTrials.gov Identifier: NCT01323712 |
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Recruitment Status
: Unknown
Verified December 2013 by St George's, University of London.
Recruitment status was: Active, not recruiting
First Posted
: March 28, 2011
Last Update Posted
: December 9, 2013
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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
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease | Dietary Supplement: Vitamin D Cholecalciferol | Phase 2 Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | March 2011 |
| Estimated Primary Completion Date : | March 2014 |
| Estimated Study Completion Date : | May 2014 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Dietary Supplement: Vitamin D Cholecalciferol
Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks
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Primary Outcome Measures
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- Left ventricular mass [ Time Frame: 52 weeks ]
Secondary Outcome Measures
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- Cardiac systolic and diastolic function [ Time Frame: 52 weeks ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| 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 ( Other Grant/Funding Number: BRITISH HEART FOUNDATION ) |
| First Posted: | March 28, 2011 Key Record Dates |
| Last Update Posted: | December 9, 2013 |
| Last Verified: | December 2013 |
Keywords provided by St George's, University of London:
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CKD LV mass Vitamin D LV function |
Additional relevant MeSH terms:
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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 |