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Vitamin D Supplementation and Cardiac Hypertrophy in Chronic Kidney Disease (CKD) (5C)

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ClinicalTrials.gov Identifier: NCT01323712
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
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
St George's, University of London

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Vitamin D Cholecalciferol
Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks



Primary Outcome Measures :
  1. Left ventricular mass [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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:
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