NCT01005303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

December 1, 2023

Completed
Last Updated

December 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4.5 years

First QC Date

October 29, 2009

Results QC Date

October 28, 2021

Last Update Submit

February 23, 2023

Conditions

Heart Failure

Keywords

Heart FailureMicronutrientsVitamin DInflammationOxidative StressQuality of LifePhysical Functioning

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Ejection Fraction

    Baseline, and 12 months

Secondary Outcomes (8)

  • Quality of Life Questionnaire Score

    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

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Micronutrient

ACTIVE COMPARATOR
Drug: Forceval plus 50 micrograms Vitamin D3

Interventions

PlaceboDRUG

1 Tablet Daily

Placebo
Forceval plus 50 micrograms Vitamin D3DRUG

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

Micronutrient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24952700DERIVED

MeSH Terms

Conditions

Heart FailureInflammation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Nick McKeag
Organization
Belfast Health and Social Care Trust
nick.mckeag@belfasttrust.hscni.net
02895048487

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

July 1, 2015

Last Updated

December 1, 2023

Results First Posted

December 1, 2023

Record last verified: 2023-02

Locations

GB(1)