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The Role of Vitamin D in the Pathophysiology of Chronic Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Chronic Heart Failure Drug: Vitamin D Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation
Study Start Date : January 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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).
Drug: Vitamin D



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01993537


Locations
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Canada, Ontario
The University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Haissam Haddad The University of Ottawa Heart Insitute

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Responsible Party: Haissam Haddad, Director Heart Failure Program, Medical Director Heart Transplant Program, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01993537     History of Changes
Other Study ID Numbers: 20120585
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Heart Failure
Vitamin D Deficiency
Heart Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents