Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 3:07 PM
Study NCT ID:
NCT01005303
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2009-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Micronutrient Supplementation in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nick.mckeag@belfasttrust.hscni.net', 'phone': '02895048487', 'title': 'Dr Nick McKeag', 'organization': 'Belfast Health and Social Care Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 10}], 'seriousEvents': [{'term': 'Hospital Admission', 'notes': 'Hospital admission for any reason', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.7', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '44.9', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'percentage of LVEF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '33.7', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '22.6', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '38.2', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Test Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '437.8', 'spread': '94.9', 'groupId': 'OG000'}, {'value': '417.0', 'spread': '120.1', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '440.2', 'spread': '98.6', 'groupId': 'OG000'}, {'value': '412.5', 'spread': '114.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'Metres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Result not available for 6 patients: all were unable to perform six minute walk test due to joint disease / poor mobility.'}, {'type': 'SECONDARY', 'title': 'Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '841.6', 'spread': '1137.9', 'groupId': 'OG000'}, {'value': '1293.4', 'spread': '2064.1', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1343.6', 'spread': '2983.7', 'groupId': 'OG000'}, {'value': '1763.6', 'spread': '5024.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum C-reactive Protein (CRP) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '15.0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Result not available for 3 patients: all due to quality control (intra-assay coefficient of variation \\> 25%).'}, {'type': 'SECONDARY', 'title': 'Serum Interleukin-6 (IL-6) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '5.0', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Result not available for 5 patients: all due to quality control (intra-assay coefficient of variation \\> 25%).'}, {'type': 'SECONDARY', 'title': 'Serum Interleukin-10 (IL-10) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Result not available for 10 patients: all due to due to quality control (intra-assay coefficient of variation \\> 25%).'}, {'type': 'SECONDARY', 'title': 'Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'OG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.3', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '11.7', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 12 months', 'unitOfMeasure': 'mol/mmol creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'FG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': '3 patients did not complete the study protocol (2 developed illnesses during the first 3 months of follow-up, requiring withdrawal from the study, and 1 died approximately 6 months into the study).', 'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: 1 Tablet Daily'}, {'id': 'BG001', 'title': 'Micronutrient', 'description': 'Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left Ventricular Ejection Fraction', 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of LVEF', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'New York Heart Association Functional Class II', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association Functional Class III', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants'}, {'title': 'Aetiology Ischaemic', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aetiology Non-Ischaemic', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Beta-Blocker', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mineralocorticoid Receptor Antagonist', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Implantable Cardioverter Defibrillator', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac Resynchronisation Therapy', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2009-10-29', 'resultsFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-23', 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': 'Baseline, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Questionnaire Score', 'timeFrame': 'Baseline, and 12 months', 'description': "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."}, {'measure': 'Six Minute Walk Test Distance', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Serum C-reactive Protein (CRP) Concentration', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Serum Interleukin-6 (IL-6) Concentration', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Serum Interleukin-10 (IL-10) Concentration', 'timeFrame': 'Baseline, and 12 months'}, {'measure': 'Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration', 'timeFrame': 'Baseline, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Micronutrients', 'Vitamin D', 'Inflammation', 'Oxidative Stress', 'Quality of Life', 'Physical Functioning'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24952700', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New York Heart Association Class II and III\n* Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)\n* Stable for a period of at least 6 weeks\n* Left ventricular ejection fraction less than or equal to 45%\n\nExclusion Criteria:\n\n* History of significant alcohol ingestion (more than 40 units per week)\n* Severe renal dysfunction (GFR less than 30ml/min)\n* Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)\n* Atrial fibrillation (in the absence of a pacemaker)\n* Frequent ventricular ectopics\n* On waiting list for cardiac transplantation\n* Uncontrolled diabetes mellitus\n* Inability to give informed consent\n* Estimated life span less than 12 months\n* Already taking a multivitamin/mineral supplement\n* Already taking a vitamin-D containing fish oil\n* Woman of child-bearing potential\n* History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance'}, 'identificationModule': {'nctId': 'NCT01005303', 'acronym': 'MINT-HF', 'briefTitle': 'Micronutrient Supplementation in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Belfast Health and Social Care Trust'}, 'officialTitle': 'A Trial of Micronutrient Supplementation in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'RGHT000395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Micronutrient', 'interventionNames': ['Drug: Forceval plus 50 micrograms Vitamin D3']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '1 Tablet Daily', 'armGroupLabels': ['Placebo']}, {'name': 'Forceval plus 50 micrograms Vitamin D3', 'type': 'DRUG', 'description': 'Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily', 'armGroupLabels': ['Micronutrient']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Pascal McKeown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Belfast Health and Social Care Trust'}, {'name': 'Mark Harbinson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belfast Health and Socail Care Trust'}, {'name': 'Michelle McKinley, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Queen's Univeristy of Belfast"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pascal McKeown', 'investigatorAffiliation': 'Belfast Health and Social Care Trust'}}}}