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The Role of Vitamin D in the Pathophysiology of Chronic Failure

Primary Purpose

Vitamin D Deficiency, Chronic Heart Failure

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Sufficeint

Mild Insufficiency

Severe Deficiency no treatment

Severe Deficiency - Treatment

Arm Description

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.

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.

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01993537

First Posted

October 4, 2013

Last Updated

March 2, 2016

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01993537

Brief Title

The Role of Vitamin D in the Pathophysiology of Chronic Failure

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 Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Chronic Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sufficeint

Arm Type

No Intervention

Arm Description

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.

Arm Title

Mild Insufficiency

Arm Type

No Intervention

Arm Description

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.

Arm Title

Severe Deficiency no treatment

Arm Type

No Intervention

Arm Description

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.

Arm Title

Severe Deficiency - Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haissam Haddad

Organizational Affiliation

The University of Ottawa Heart Insitute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

The Role of Vitamin D in the Pathophysiology of Chronic Failure

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