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Micronutrient Supplementation in Patients With Heart Failure

NCT ID: NCT01005303

Last Updated: 2023-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 Tablet Daily

Micronutrient

Group Type ACTIVE_COMPARATOR

Forceval plus 50 micrograms Vitamin D3

Intervention Type DRUG

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

Interventions

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Placebo

1 Tablet Daily

Intervention Type DRUG

Forceval plus 50 micrograms Vitamin D3

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role lead

Responsible Party

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Pascal McKeown

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pascal McKeown, MD

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Mark Harbinson, MD

Role: STUDY_DIRECTOR

Belfast Health and Socail Care Trust

Michelle McKinley, PhD

Role: STUDY_DIRECTOR

The Queen's Univeristy of Belfast

Locations

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Royal Victoria Hospital

Belfast, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24952700 (View on PubMed)

Other Identifiers

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RGHT000395

Identifier Type: -

Identifier Source: org_study_id