The Role of Vitamin D in the Pathophysiology of Chronic Failure

University of Ottawa Heart Institute

Status and phase: Completed; Phase 4

Conditions: Chronic Heart Failure; Vitamin D Deficiency

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01993537

20120585

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 4 patient groups

Sufficeint

No Intervention group

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.

Mild Insufficiency

No Intervention group

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.

Severe Deficiency no treatment

No Intervention group

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.

Severe Deficiency - Treatment

Experimental group

Description:

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).

Treatment:

Drug: Vitamin D