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A Trial of Thiamin Supplementation in Patients With Heart Failure

NCT00959075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-02-27

No results posted yet for this study

Summary

Background: Patients with heart failure (HF) are at increased risk of developing thiamin deficiency (TD). Thiamin (vitamin B1) is required for the production of energy and therefore TD may contribute to the energy depletion commonly observed in the failing heart. Thiamin supplementation trials to date have shown conflicting results and therefore further studies to explain the impact of thiamin supplementation on HF patients with TD is necessary.

Objective: The purpose of this study is to determine whether thiamin supplementation in an ambulatory cohort of patients with systolic heart failure will provide any benefit in terms of improved heart function, symptoms, exercise capacity, and quality of life.

Description: Patients involved in the study will be given either thiamin supplements or a matching placebo (pills containing no thiamin) for 6 months. The ability of the heart to pump before and after the supplementation will be measured using cardiac magnetic resonance imaging (MRI)and/or 3D echocardiography.

Relevance: This study will determine whether thiamin supplementation improves cardiac function, exercise tolerance and quality of life. Thiamin supplementation is widely available, inexpensive, and safe. Therefore this trial may have a major impact on the optimal management of the expanding population of heart failure patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin B1

100 mg Twice a day

DIETARY_SUPPLEMENT

Placebo

Sugar pill

Sponsors & Collaborators

  • Heart and Stroke Foundation of Ontario

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Mary E. Keith, PhD, RD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00959075 on ClinicalTrials.gov