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
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|
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:
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
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
|The University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Haissam Haddad||The University of Ottawa Heart Insitute|