The Role of Vitamin D in the Pathophysiology of Chronic Failure

NCT ID: NCT01993537

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

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

Conditions

Vitamin D Deficiency; Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Interventions

Vitamin D

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Haissam Haddad

Director Heart Failure Program, Medical Director Heart Transplant Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haissam Haddad

Role: PRINCIPAL_INVESTIGATOR

The University of Ottawa Heart Insitute

Locations

The University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20120585

Identifier Type: -

Identifier Source: org_study_id