The Role of Vitamin D in the Pathophysiology of Chronic Failure

The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Chronic Heart Failure
• Intervention / Treatment: Drug: Vitamin D

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • The University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
No Intervention: 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.
No Intervention: 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.
Experimental: 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).	Drug: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Haissam Haddad, The University of Ottawa Heart Insitute

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimated): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Secosteroids; Vitamin D
• Other Study ID Numbers: 20120585