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The Role of Vitamin D in the Pathophysiology of Chronic Failure

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ClinicalTrials.gov Identifier: NCT01993537
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Haissam Haddad, Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE October 4, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute [ Time Frame: up to 3 years ]
The primary outcome for the study is to identify the prevalence of Vitamin D deficiency amongst chronic heart failure patients followed at the University of Ottawa Heart Institute. This will be done analyzing the Vitamin D blood levels at baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01993537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit [ Time Frame: up to 3 years ]
clinical endpoints of: hospitalizations for worsening congestive heart failure, death will be compared for severe Vitamin D deficient patients receiving Vitamin D supplementation vs severe Vitamin D deficient patients receiving no intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Vitamin D in the Pathophysiology of Chronic Failure
Official Title  ICMJE The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation
Brief Summary

Patients will undergo at baseline and regular intervals:

  • clinically indicated bloodwork/urine and echocardiogram testing
  • biomarker studies

Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.

Detailed Description

The inclusion criteria for the study is:

  • an EF ≤40% within the last 12 months before recruitment
  • established diagnosis of heart failure
  • >18 years of age
  • patients will vitamin d levels of sufficient, mild deficiency and severe deficiency

The exclusion criteria is:

  • hypercalcemia
  • known hypersensitivity to Vitamin D
  • patient unwilling to comply with study requirements
  • any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
  • women of child bearing potential
  • a patient currently taking vitamin d
  • severe renal impairment estimated glomerular filtration rate (eGFR) <30
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin D Deficiency
  • Chronic Heart Failure
Intervention  ICMJE Drug: Vitamin D
Study Arms  ICMJE
  • No Intervention: Sufficeint
    In this arm the participants have a Vitamin D level of greater than 75 ng/ml. They will continue to be monitored throughout the study but will not receive any intervention.
  • No Intervention: Mild Insufficiency
    In this arm the participants have a Vitamin D level between 37.5 - 75 ng/ml. The participants will be monitored throughout the study but will receive no intervention.
  • No Intervention: Severe Deficiency no treatment
    In this arm the participants have a low Vitamin D level of less than 37.5 ng/ml. The participants will be monitored but will receive no intervention.
  • Experimental: Severe Deficiency - Treatment
    In this arm the participants will be treated with Vitamin D. The participants will be prescribed a dose of 1000 IU a day (1 pill a day). At 6 weeks the dosage will increase to 2000 IU a day (2 pills a day).
    Intervention: Drug: Vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2016)
91
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
120
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • an ejection fraction (EF) ≤40% within the last 12 months before recruitment
  • established diagnosis of heart failure
  • >18 years of age
  • patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency

Exclusion Criteria:

  • hypercalcemia
  • known hypersensitivity to Vitamin D
  • patient unwilling to comply with study requirements
  • any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
  • women of child bearing potential
  • a patient currently taking vitamin d
  • severe renal impairment eGFR <30
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993537
Other Study ID Numbers  ICMJE 20120585
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haissam Haddad, Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haissam Haddad The University of Ottawa Heart Insitute
PRS Account Ottawa Heart Institute Research Corporation
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP