Micronutrient Supplementation in Patients With Heart Failure

A Trial of Micronutrient Supplementation in Patients With Heart Failure

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005303

Acronym

MINT-HF

Enrollment

Registered

2009-10-30

Start date

2009-02-28

Completion date

2015-07-31

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning

Brief summary

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.

Interventions

DRUGPlacebo

1 Tablet Daily

DRUGForceval plus 50 micrograms Vitamin D3

Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* New York Heart Association Class II and III * Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker) * Stable for a period of at least 6 weeks * Left ventricular ejection fraction less than or equal to 45%

Exclusion criteria

* History of significant alcohol ingestion (more than 40 units per week) * Severe renal dysfunction (GFR less than 30ml/min) * Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal) * Atrial fibrillation (in the absence of a pacemaker) * Frequent ventricular ectopics * On waiting list for cardiac transplantation * Uncontrolled diabetes mellitus * Inability to give informed consent * Estimated life span less than 12 months * Already taking a multivitamin/mineral supplement * Already taking a vitamin-D containing fish oil * Woman of child-bearing potential * History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance

Design outcomes

Primary

Measure	Time frame
Left Ventricular Ejection Fraction	Baseline, and 12 months

Secondary

Measure	Time frame	Description
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	—
Quality of Life Questionnaire Score	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.
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	—
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration	Baseline, and 12 months	—

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Placebo Placebo: 1 Tablet Daily	36
Micronutrient Forceval plus 50 micrograms Vitamin D3: Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily	38
Total	74

Baseline characteristics

Characteristic	Total	Micronutrient	Placebo
Aetiology Ischaemic	47 Participants	28 Participants	19 Participants
Aetiology Non-Ischaemic	27 Participants	10 Participants	17 Participants
Age, Continuous	64.3 Years STANDARD_DEVIATION 9.3	65.8 Years STANDARD_DEVIATION 9.4	62.7 Years STANDARD_DEVIATION 9
Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker	72 Participants	36 Participants	36 Participants
Beta-Blocker	70 Participants	36 Participants	34 Participants
Cardiac Resynchronisation Therapy	22 Participants	12 Participants	10 Participants
Implantable Cardioverter Defibrillator	42 Participants	24 Participants	18 Participants
Left Ventricular Ejection Fraction	41.6 percentage of LVEF STANDARD_DEVIATION 10.8	38.3 percentage of LVEF STANDARD_DEVIATION 11.4	45.1 percentage of LVEF STANDARD_DEVIATION 9
Mineralocorticoid Receptor Antagonist	37 Participants	24 Participants	13 Participants
New York Heart Association Functional Class II	58 Participants	28 Participants	30 Participants
New York Heart Association Functional Class III	16 Participants	10 Participants	6 Participants
Sex: Female, Male Female	14 Participants	7 Participants	7 Participants
Sex: Female, Male Male	60 Participants	31 Participants	29 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 36	1 / 38
other Total, other adverse events	0 / 36	0 / 30
serious Total, serious adverse events	18 / 36	10 / 38