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

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
Hypertrophy
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Cardiomegaly
Pathological Conditions, Anatomical
Urologic Diseases
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 29, 2014