The Role of Vitamin D in the Pathophysiology of Chronic Failure

NCT01993537 | Completed Phase 4 DMC

• 1 other identifier: 20120585
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 3 years

Study Arms (4)

Sufficeint

NO INTERVENTION

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.

Mild Insufficiency

NO INTERVENTION

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.

Severe Deficiency no treatment

NO INTERVENTION

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.

Severe Deficiency - Treatment

EXPERIMENTAL

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

Interventions

Vitamin D DRUG

Severe Deficiency - Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Haissam Haddad

  The University of Ottawa Heart Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 6, 2026

Record last verified: 2016-03

Locations

CA (1)