Vitamin D DeficiencyPhase 4NCT01993537
The Role of Vitamin D in the Pathophysiology of Chronic Failure
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency and Chronic Heart Failure, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vitamin D Deficiency, Chronic Heart Failure
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haissam Haddad, Principal investigator, The University of Ottawa Heart Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993537
- Sponsor's protocol ID
- 20120585
- Status last verified
- Mar 2016
- First submitted
- 4 Oct 2013
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01993537
- Acronym / sponsor ID
- 20120585
- Conditions
- Vitamin D Deficiency, Chronic Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Vitamin DIn 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D | Drug | Severe Deficiency - Treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haissam Haddad principal investigator
The University of Ottawa Heart Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Vitamin D Deficiency and Chronic Heart Failure, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.