The Role of Vitamin D in the Pathophysiology of Chronic Failure

Vitamin D Deficiency Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Vitamin D Deficiency

• NCT number: NCT01993537
• Study type: Interventional
• Source: Ottawa Heart Institute Research Corporation
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Completion date: January 2016