Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD)

Recruiting

• Source

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  Public Title	Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD)
  Acronym	5C
  Source of Record URL	http://clinicaltrials.gov/show/NCT01323712

• Trial

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  Health Condition(s) or Problem	Chronic Kidney Disease
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	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
  Who cannot enter the trial	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
  What will happen	Dietary Supplement; Vitamin D Cholecalciferol; Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks
  Primary aim	Left ventricular mass
  Secondary Aim	Cardiac systolic and diastolic function; 52 weeks; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	London

• Contact

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  Contact for Public Queries	Debasish Banerjee, MD FRCP 442087251673 debasish.banerjee@stgeorges.nhs.uk Debasish Banerjee, MD FRCP Principal Investigator St George's, University of London
  Contact for Scientific Queries	Nihil Chitalia, MRCP; Sub-Investigator; Juan C Kaski, DSc FRCP; Sub-Investigator; David Goldsmith, FRCP; Principal Investigator