The Role of Vitamin D in the Pathophysiology of Chronic Failure

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993537
• Other study ID #: 20120585
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2013
• Last updated: March 2, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D

Locations

Country	Name	City	State
Canada	The University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute	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.	up to 3 years	No
Secondary	To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit	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	up to 3 years	No