The Role of Vitamin D in the Pathophysiology of Chronic Failure

Phase 4

Completed

• Conditions: Chronic Heart Failure; Vitamin D Deficiency
• Interventions: Drug: Vitamin D

• Registration Number: NCT01993537
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Deficiency - Treatment	Vitamin D	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).

Primary Outcome Measures

Name	Time	Method
prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute	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

Name	Time	Method
To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit	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

Trial Locations

Locations (1)

The University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada