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Completed

NCT Number: NCT01993537

The Role of Vitamin D in the Pathophysiology of Chronic Failure

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Chronic Heart Failure Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Primary outcomes

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

    Time frame: up to 3 years

    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.

Secondary outcomes

  1. To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit

    Time frame: up to 3 years

    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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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