NCT01993537

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Vitamin D

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-11-25
• Last updated: 2016-03-03

Locations

1 site across 1 country: Canada