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Vitamin D3 Supplementation for Heart Failure Patients

Primary Purpose

Heart Failure, Vitamin D Deficiency, Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo Comparator: Sugar Pill
Vitamin D3 (cholecalciferol)
Sponsored by
Heidi Moretti, MS, RD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Vitamin D, Cholecalciferol, Heart Failure, Congestive heart failure, Cardiomyopathy, Strength, Parathyroid Hormone, Calcium, Quality of Life, C reactive protein, Cardiopulmonary exercise testing, Prognosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • International Heart Institute of Montana
  • Saint Patrick Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3 (cholecalciferol)

Sugar Pill

Arm Description

10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.

Patients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
C reactive protein (CRP)
CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels.
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.
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)
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.

Full Information

First Posted
July 3, 2012
Last Updated
April 24, 2017
Sponsor
Heidi Moretti, MS, RD
Collaborators
Saint Patrick Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01636570
Brief Title
Vitamin D3 Supplementation for Heart Failure Patients
Official Title
Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heidi Moretti, MS, RD
Collaborators
Saint Patrick Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Vitamin D Deficiency, Cardiomyopathy, Congestive Heart Failure
Keywords
Vitamin D, Cholecalciferol, Heart Failure, Congestive heart failure, Cardiomyopathy, Strength, Parathyroid Hormone, Calcium, Quality of Life, C reactive protein, Cardiopulmonary exercise testing, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 (cholecalciferol)
Arm Type
Active Comparator
Arm Description
10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Patients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: Sugar Pill
Other Intervention Name(s)
Bio-tech Pharmacal
Intervention Description
Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 (cholecalciferol)
Other Intervention Name(s)
Bio-tech Pharmacal
Intervention Description
10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.
Primary Outcome Measure Information:
Title
B type Natriuretic Peptide (BNP)
Description
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.
Time Frame
Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test (CPX)
Description
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)
Time Frame
Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo
Title
25 hydroxyvitamin D [25 (OH)D]
Description
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.
Time Frame
Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo
Title
C reactive protein (CRP)
Description
CRP is related to heart failure incidence, and vitamin D seems to be inversely related to CRP levels.
Time Frame
Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
Title
Serum Calcium
Description
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.
Time Frame
Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo
Title
6 minute walk test
Description
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)
Time Frame
Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo
Title
Kansas City Cardiomyopathy Questionnaire
Description
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.
Time Frame
Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley D Berry, MD
Organizational Affiliation
International Heart Institute of Montana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heidi D Moretti, MS, RD
Organizational Affiliation
Saint Patrick Hospital
Official's Role
Study Director
Facility Information:
Facility Name
International Heart Institute of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hosptial
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29084522
Citation
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.
Results Reference
derived

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Vitamin D3 Supplementation for Heart Failure Patients

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