Heart FailureNCT01125436
A Trial of Vitamin D Therapy in Patients With Heart Failure
A study testing Cholecalciferol in people with Heart Failure, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) class II-IV
- Able to walk
- Serum 25OHD level 37.5 ng/ml or less
- Fully titrated on heart failure medications
Who cannot join
- Osteoporosis
- Primary hyperparathyroidism or hypercalcemia.
- Nephrolithiasis
- Hemo or peritoneal dialysis and/or creatinine of > 2.5
- Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
- Current illicit drug user or > 3 alcoholic drinks a day
Show all 9Show fewer
- Metastatic or advanced cancer
- Myocardial infarction in the preceding 6 months
- Medications which can lower vitamin D levels or bioavailability
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals/Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Read the detailed description
The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.
A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients > 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.
- Conditions
- Heart Failure
- Being tested
- Cholecalciferol
- Keywords
- Aerobic Capacity, Strength
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Vitamin D
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
CholecalciferolDietary supplement
Weekly placebo plus 800 calcium alone
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Nutritional supplement Receives: Dietary Supplement: Cholecalciferol |
| placebo | Placebo comparator | Weekly placebo plus 800 calcium daily Receives: Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
Measured: change from baseline to 6 months
Secondary outcomes (3)
Leg Proximal Muscle Strength
Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension
Measured: change from baseline to 6 months
6 Minute Walk Distance
The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL).
Measured: Change from baseline to 6 months
Timed Get Up and Go
stand from chair walk 3 meters, return to chair and sit
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Boxer, MD, Principal investigator, Case Western Reserve Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125436
- Sponsor's protocol ID
- 1KL2RR024990
- Status last verified
- Jul 2022
- First submitted
- 17 May 2010
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01125436
- Acronym / sponsor ID
- 1KL2RR024990
- Conditions
- Heart Failure
- Keywords
- Aerobic Capacity, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Detailed description
The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.
A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients > 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Dietary Supplement: CholecalciferolNutritional supplement |
| placebo | Placebo comparator | Dietary Supplement: CholecalciferolWeekly placebo plus 800 calcium daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- New York Heart Association (NYHA) class II-IV
- Able to walk
- Serum 25OHD level 37.5 ng/ml or less
- Fully titrated on heart failure medications
Key exclusion criteria (9 listed)
- Osteoporosis
- Primary hyperparathyroidism or hypercalcemia.
- Nephrolithiasis
- Hemo or peritoneal dialysis and/or creatinine of > 2.5
- Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily | Dietary supplement | Cholecalciferol |
| CholecalciferolWeekly placebo plus 800 calcium alone | Dietary supplement | placebo |
Primary outcome
Peak VO2
Time frame: change from baseline to 6 months
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
3 secondary outcomes
Leg Proximal Muscle Strength
Time frame: change from baseline to 6 months
6 Minute Walk Distance
Time frame: Change from baseline to 6 months
Timed Get Up and Go
Time frame: Change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heart Failure
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Rebecca Boxer, MD principal investigator
Case Western Reserve Univerity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Heart Failure, run by Case Western Reserve University at 1 site in United States.
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 9 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 10 Aug 2022. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak VO2 (time frame: change from baseline to 6 months). 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 10 Aug 2022.