Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2012-08-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D3 (cholecalciferol)
10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.
Vitamin D3 (cholecalciferol)
10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.
Sugar Pill
Patients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day.
Placebo Comparator: Sugar Pill
Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.
Interventions
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Placebo Comparator: Sugar Pill
Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.
Vitamin D3 (cholecalciferol)
10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
ALL
No
Sponsors
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Saint Patrick Hospital
OTHER
Heidi Moretti, MS, RD
OTHER
Responsible Party
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Heidi Moretti, MS, RD
Co-Investigator
Principal Investigators
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Bradley D Berry, MD
Role: PRINCIPAL_INVESTIGATOR
International Heart Institute of Montana
Heidi D Moretti, MS, RD
Role: STUDY_DIRECTOR
Saint Patrick Hospital
Locations
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International Heart Institute of Montana
Missoula, Montana, United States
Saint Patrick Hosptial
Missoula, Montana, United States
Countries
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References
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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.
Other Identifiers
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VitD3HF
Identifier Type: -
Identifier Source: org_study_id
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