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Heart FailurePhase 2NCT01636570

Vitamin D3 Supplementation for Heart Failure Patients

A Phase 2 study testing Vitamin D3 (cholecalciferol) in people with Heart Failure and Vitamin D Deficiency, run by Heidi Moretti, MS, RD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. Read more about this study

Who is it for?
Any age
What is being tested?
Vitamin D3 (cholecalciferol)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesUnited States
Study dates
Aug 2012to Apr 2015
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • NYHA Heart Failure Class II or II, stable
  • Vitamin D deficiency (32 ng/ml or less)
  • No recent medication changes for 3 months
  • Females of childbearing age must use effective contraceptive if they are sexually active

Who cannot join

  • Hypercalcemia
  • Nephrolithiases
  • Sarcoidosis
  • Acute cardiac insufficiency
  • Pregnancy
  • Breastfeeding
  • Any clinically unstable medical condition
  • Supplements of greater than or equal to 1000 units of vitamin D per day

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • International Heart Institute of Montana

    Missoula, Montana, 59802

  • Saint Patrick Hosptial

    Missoula, Montana, 59802

Other trials in United States

About this study

Official title: Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients

The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in patients with stable congestive heart failure (Class II or III).

Being tested
Placebo Comparator: Sugar Pill, Vitamin D3 (cholecalciferol)
Keywords
Vitamin D, Cholecalciferol, Heart Failure, Congestive heart failure, Cardiomyopathy, Strength, Parathyroid Hormone, Calcium, Quality of Life, C reactive protein, Cardiopulmonary exercise testing, Prognosis
Medical subject headings
Heart Failure, Vitamin D Deficiency, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Comparator: Sugar PillDrug

    Also called Bio-tech Pharmacal

    Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.

  • Vitamin D3 (cholecalciferol)Drug

    Also called Bio-tech Pharmacal

    10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.

Study groups in NCT01636570
Study groupRoleWhat they receive
Vitamin D3 (cholecalciferol)Active comparator10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.
Receives: Drug: Vitamin D3 (cholecalciferol)
Sugar PillPlacebo comparatorPatients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day.
Receives: Drug: Placebo Comparator: Sugar Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. B type Natriuretic Peptide (BNP)

    BNP is a hormone secreted by the heart ventricles, and high concentrations of this hormone occur in heart failure. It is a strong prognostic indicator.

    Measured: Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo

Secondary outcomes (6)

  1. Cardiopulmonary exercise test (CPX)

    Secondary outcome measure will include improvements from baseline in cardiopulmonary function as evaluated by CPX(includes measurement of the change in ventilator efficiency (VE/VCO2), partial pressure of end-tidal CO2 (PETCO2)

    Measured: Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo

  2. 25 hydroxyvitamin D [25 (OH)D]

    Patients with vitamin D deficiency as defined by 25(OH)D of less than 32 ng/ml. 25(OH)D is the most accurate measurement for assessment of vitamin D status. However, ideal ranges for serum 25 (OH)D have not been well established. A recent pharmokinetic study conducted by Hollis, et al, found that 25 OHD levels had to exceed 40 ng/ml and sometimes 50 ng/ml, for the parent substrate (cholecalciferol) to be detectable in the blood (Hollis 2007. IF 25(OH)D levels exceed 150 ng/ml, they will be withdrawn from the study to avoid toxicity.

    Measured: Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo

  3. C reactive protein (CRP)

    CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels.

    Measured: Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo

  4. Serum Calcium

    Measurement of serum calcium levels will help to assess safety of vitamin D treatment. If serum calcium becomes elevated, patients will be withdrawn from the clinical trial.

    Measured: Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo

  5. 6 minute walk test

    The 6 minute walk test is used to measure aerobic activity at baseline and after completion of supplemental vitamin D or placebo. This test is an objective measurement of exercise capacity, and has been shown to be reproducible and a suitable measure for outcome in patients with heart failure (Guyatt). The 6 minute walk test in heart failure patients is strongly associated with vitamin D serum concentrations (p=0.002) and inversely with high sensitivity C reactive protein (hsCRP), an inflammatory marker (p=0.001)

    Measured: Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo

  6. Kansas City Cardiomyopathy Questionnaire

    Measurements of quality of life provide means of measuring prospective benefits of heart failure interventions. The KCCQ is associated with hospitalization and mortality, and is sensitive to changes in heart function with ARB, beta-blocker and ACE inhibitor treatment.

    Measured: Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01636570
Sponsor's protocol ID
VitD3HF
Status last verified
Apr 2017
First submitted
3 Jul 2012
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Moretti HD, Colucci VJ, Berry BD. Vitamin D3 repletion versus placebo as adjunctive treatment of heart failure patient quality of life and hormonal indices: a randomized, double-blind, placebo-controlled trial. BMC Cardiovasc Disord. 2017 Oct 30;17(1):274. doi: 10.1186/s12872-017-0707-y.

    PubMed 29084522

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 (cholecalciferol) in people with Heart Failure and Vitamin D Deficiency, run by Heidi Moretti, MS, RD at 2 sites 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 8 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

B type Natriuretic Peptide (BNP) (time frame: Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01636570, which also lists 1 linked publication.

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 26 Apr 2017.

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