CompletedPhase 4

The Role of Vitamin D in the Pathophysiology of Chronic Failure

Canada91 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute

Timeframe: up to 3 years

Trial details

NCT IDNCT01993537

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Vitamin D Deficiency trials