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There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Micronutrient | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1 Tablet Daily |
| |
| Forceval plus 50 micrograms Vitamin D3 |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | Baseline, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire Score | Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal McKeown, MD | Belfast Health and Social Care Trust | Principal Investigator |
| Mark Harbinson, MD | Belfast Health and Socail Care Trust | Study Director |
| Michelle McKinley, PhD | The Queen's Univeristy of Belfast | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24952700 | Derived | McKeag NA, McKinley MC, Harbinson MT, Noad RL, Dixon LH, McGinty A, Neville CE, Woodside JV, McKeown PP. The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial. JACC Heart Fail. 2014 Jun;2(3):308-17. doi: 10.1016/j.jchf.2013.12.008. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: 1 Tablet Daily |
| FG001 | Micronutrient | Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: 1 Tablet Daily |
| BG001 | Micronutrient | Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Ejection Fraction | Result not available for 3 patients: 1 patient was unable to attend for 12 month scan due to personal reasons, 1 patient was unable to attend due to illness and images from 1 patient of inadequate quality for analysis. | Posted | Mean | Standard Deviation | percentage of LVEF | Baseline, and 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: 1 Tablet Daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Admission | Cardiac disorders | Systematic Assessment | Hospital admission for any reason |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nick McKeag | Belfast Health and Social Care Trust | 02895048487 | nick.mckeag@belfasttrust.hscni.net |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily |
|
| Baseline, and 12 months |
| Six Minute Walk Test Distance | Baseline, and 12 months |
| Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration | Baseline, and 12 months |
| Serum C-reactive Protein (CRP) Concentration | Baseline, and 12 months |
| Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration | Baseline, and 12 months |
| Serum Interleukin-6 (IL-6) Concentration | Baseline, and 12 months |
| Serum Interleukin-10 (IL-10) Concentration | Baseline, and 12 months |
| Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration | Baseline, and 12 months |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Left Ventricular Ejection Fraction | Mean | Standard Deviation | percentage of LVEF |
|
| New York Heart Association Functional Class II | New York Heart Association Functional Class II = Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). This was assessed via clinical history. | Count of Participants | Participants |
|
| New York Heart Association Functional Class III | New York Heart Association Functional Class III = Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.This was assessed via clinical history. | Count of Participants | Participants |
|
| Aetiology Ischaemic | Count of Participants | Participants |
|
| Aetiology Non-Ischaemic | Count of Participants | Participants |
|
| Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker | Count of Participants | Participants |
|
| Beta-Blocker | Count of Participants | Participants |
|
| Mineralocorticoid Receptor Antagonist | Count of Participants | Participants |
|
| Implantable Cardioverter Defibrillator | Count of Participants | Participants |
|
| Cardiac Resynchronisation Therapy | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Quality of Life Questionnaire Score | Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline, and 12 months |
|
|
|
| Secondary | Six Minute Walk Test Distance | Result not available for 6 patients: all were unable to perform six minute walk test due to joint disease / poor mobility. | Posted | Mean | Standard Deviation | Metres | Baseline, and 12 months |
|
|
|
| Secondary | Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration | Posted | Mean | Standard Deviation | ng/L | Baseline, and 12 months |
|
|
|
| Secondary | Serum C-reactive Protein (CRP) Concentration | Posted | Mean | Standard Deviation | mg/L | Baseline, and 12 months |
|
|
|
| Secondary | Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration | Result not available for 3 patients: all due to quality control (intra-assay coefficient of variation > 25%). | Posted | Mean | Standard Deviation | pg/mL | Baseline, and 12 months |
|
|
|
| Secondary | Serum Interleukin-6 (IL-6) Concentration | Result not available for 5 patients: all due to quality control (intra-assay coefficient of variation > 25%). | Posted | Mean | Standard Deviation | pg/mL | Baseline, and 12 months |
|
|
|
| Secondary | Serum Interleukin-10 (IL-10) Concentration | Result not available for 10 patients: all due to due to quality control (intra-assay coefficient of variation > 25%). | Posted | Mean | Standard Deviation | pg/mL | Baseline, and 12 months |
|
|
|
| Secondary | Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration | Posted | Mean | Standard Deviation | mol/mmol creatinine | Baseline, and 12 months |
|
|
|
| 36 |
| 18 |
| 36 |
| 0 |
| 36 |
| EG001 | Micronutrient | Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily | 1 | 38 | 10 | 38 | 0 | 30 |
|
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