Trial Outcomes & Findings for Micronutrient Supplementation in Patients With Heart Failure (NCT NCT01005303)

NCT ID: NCT01005303

Last Updated: 2023-12-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

79 participants

Primary outcome timeframe

Baseline, and 12 months

Results posted on

2023-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo: 1 Tablet Daily	Micronutrient Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Overall Study STARTED	36	38
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Micronutrient Supplementation in Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=36 Participants Placebo: 1 Tablet Daily	Micronutrient n=38 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily	Total n=74 Participants Total of all reporting groups
Age, Continuous	62.7 Years STANDARD_DEVIATION 9.0 • n=5 Participants	65.8 Years STANDARD_DEVIATION 9.4 • n=7 Participants	64.3 Years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Left Ventricular Ejection Fraction	45.1 percentage of LVEF STANDARD_DEVIATION 9.0 • n=5 Participants	38.3 percentage of LVEF STANDARD_DEVIATION 11.4 • n=7 Participants	41.6 percentage of LVEF STANDARD_DEVIATION 10.8 • n=5 Participants
New York Heart Association Functional Class II	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
New York Heart Association Functional Class III	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Aetiology Ischaemic	19 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants
Aetiology Non-Ischaemic	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Beta-Blocker	34 Participants n=5 Participants	36 Participants n=7 Participants	70 Participants n=5 Participants
Mineralocorticoid Receptor Antagonist	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Implantable Cardioverter Defibrillator	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Cardiac Resynchronisation Therapy	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, and 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo: 1 Tablet Daily	Micronutrient n=33 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Left Ventricular Ejection Fraction Baseline	44.7 percentage of LVEF Standard Deviation 8.8	38.9 percentage of LVEF Standard Deviation 11.1
Left Ventricular Ejection Fraction 12 months	44.9 percentage of LVEF Standard Deviation 12.0	38.6 percentage of LVEF Standard Deviation 10.9

SECONDARY outcome

Timeframe: Baseline, and 12 months

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.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo: 1 Tablet Daily	Micronutrient n=35 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Quality of Life Questionnaire Score Baseline	33.7 units on a scale Standard Deviation 25.2	34.0 units on a scale Standard Deviation 22.6
Quality of Life Questionnaire Score 12 months	38.2 units on a scale Standard Deviation 24.1	33.1 units on a scale Standard Deviation 21.6

SECONDARY outcome

Timeframe: Baseline, and 12 months

Population: Result not available for 6 patients: all were unable to perform six minute walk test due to joint disease / poor mobility.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Placebo: 1 Tablet Daily	Micronutrient n=33 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Six Minute Walk Test Distance Baseline	437.8 Metres Standard Deviation 94.9	417.0 Metres Standard Deviation 120.1
Six Minute Walk Test Distance 12 months	440.2 Metres Standard Deviation 98.6	412.5 Metres Standard Deviation 114.9

SECONDARY outcome

Timeframe: Baseline, and 12 months

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo: 1 Tablet Daily	Micronutrient n=35 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration Baseline	841.6 ng/L Standard Deviation 1137.9	1293.4 ng/L Standard Deviation 2064.1
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration 12 months	1343.6 ng/L Standard Deviation 2983.7	1763.6 ng/L Standard Deviation 5024.5

SECONDARY outcome

Timeframe: Baseline, and 12 months

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo: 1 Tablet Daily	Micronutrient n=35 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Serum C-reactive Protein (CRP) Concentration Baseline	5.6 mg/L Standard Deviation 8.7	6.3 mg/L Standard Deviation 15.0
Serum C-reactive Protein (CRP) Concentration 12 months	4.3 mg/L Standard Deviation 3.8	4.6 mg/L Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline, and 12 months

Population: Result not available for 3 patients: all due to quality control (intra-assay coefficient of variation \> 25%).

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Placebo: 1 Tablet Daily	Micronutrient n=35 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration Baseline	4.4 pg/mL Standard Deviation 1.5	4.1 pg/mL Standard Deviation 1.3
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration 12 months	4.6 pg/mL Standard Deviation 1.6	4.1 pg/mL Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, and 12 months

Population: Result not available for 5 patients: all due to quality control (intra-assay coefficient of variation \> 25%).

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Placebo: 1 Tablet Daily	Micronutrient n=34 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Serum Interleukin-6 (IL-6) Concentration Baseline	5.0 pg/mL Standard Deviation 6.5	7.1 pg/mL Standard Deviation 12.5
Serum Interleukin-6 (IL-6) Concentration 12 months	5.0 pg/mL Standard Deviation 6.3	4.2 pg/mL Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline, and 12 months

Population: Result not available for 10 patients: all due to due to quality control (intra-assay coefficient of variation \> 25%).

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Placebo: 1 Tablet Daily	Micronutrient n=27 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Serum Interleukin-10 (IL-10) Concentration Baseline	1.5 pg/mL Standard Deviation 2.1	1.2 pg/mL Standard Deviation 0.7
Serum Interleukin-10 (IL-10) Concentration 12 months	1.5 pg/mL Standard Deviation 1.5	1.1 pg/mL Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, and 12 months

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo: 1 Tablet Daily	Micronutrient n=35 Participants Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration Baseline	11.3 mol/mmol creatinine Standard Deviation 5.8	12.1 mol/mmol creatinine Standard Deviation 7.2
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration 12 months	11.7 mol/mmol creatinine Standard Deviation 4.6	10.5 mol/mmol creatinine Standard Deviation 3.8

Adverse Events

Placebo

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Micronutrient

Serious events: 10 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=36 participants at risk Placebo: 1 Tablet Daily	Micronutrient n=30 participants at risk；n=38 participants at risk Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Cardiac disorders Hospital Admission	50.0% 18/36 • 12 months	26.3% 10/38 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Dr Nick McKeag

Belfast Health and Social Care Trust

Phone: 02895048487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place