- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953823
The Prevalence of Thiamin Deficiency in Ambulatory Patients With Heart Failure
Study Overview
Status
Conditions
Detailed Description
Thiamin is a water-soluble B-complex vitamin which is supplied primarily from cereals and enriched grains in the ordinary diet. The majority of absorbed thiamin combines with ATP in the body to form thiamin pyrophosphate (TPP). TPP is a coenzyme which is involved in a number of energy production reactions in the body (metabolism of carbohydrates and some amino acids) . Therefore, theoretically, TD reduces the release of metabolic energy in the tissues . The adverse effects of TD include biventricular myocardial failure, tachycardia, peripheral edema, and retention of sodium which occurs as a result of heart failure . Therefore, our assumption is that TD in CHF patients may result in depletion of cellular energy and subsequently impair cardiac function. Previous studies done on CHF patients with TD found that thiamin supplementation was associated with improvement in heart contractility.
Patients with heart failure are at an increased risk for TD, for many reasons such as malnutrition, anorexia and the use of diuretic drugs, such as furosemide. Several studies have demonstrated a high prevalence of TD in hospitalized patients with heart failure, ranging from 13 % to 91% depending on the population studied. This wide variation is due to differences in the underlying nutrition status of subjects, the concurrent use of medications including loop diuretics, the severity of disease, and the measurement technique used for the assessment of thiamin status. These studies however, while clinically important, are limited by their small sample size and indirect measurement of thiamin status. Also, these studies have focused exclusively on the hospitalized patients, whereas ambulatory HF patients have received little attention.
Therefore, our primary objective to conduct a prospective, cross-sectional study to investigate the prevalence of thiamin deficiency in a large group of ambulatory patients with heart failure using High-Performance Liquid Chromatography (HPLC). This method has many advantages including its high level of recovery (102% on average), high intra- and inter-day precisions within 5-9%, as well as having a considerably low elution time of 15 min.
Our secondary objective is to conduct a trial using oral thiamin supplements alone in three practical doses in order to estimate the minimum dose of oral thiamin required to effectively replete tissue stores. We also hypothesize that oral thiamin supplementation will reduce neurohormonal stimulation (NE, BNP,as well as oxidative stress(F2-Isoprostanes).
Therefore,this study will provide critical data on the prevalence of TD in ambulatory patients with HF as well as defining what factors are predictive of TD in this population. Furthermore, this study will determine an effective dose of oral thiamin supplementation that will restore red blood cell thiamin levels. Determining an effective dose will not only justify our choice of thiamin supplementation in future studies but will guide clinicians in recommending thiamin supplementation to their patients with heart failure in the community.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with the primary diagnosis of ischemic, dilated, idiopathic or valvular HF characterized by an ejection fraction of < 45% (echocardiography or radionuclide scan)
- Patients with NYHA class I-IV symptoms
Exclusion Criteria:
- Patients who are unable or unwilling to provide informed consent
- Patients with any concurrent condition which would result in TD, namely, gastrointestinal disorders (Crohn's disease, ulcerative colitis), liver disease, prolonged diarrhoeal disease, dialysis, prolonged fever, infection or renal failure
- Patients who are rapidly deteriorating, who are not on a stable medication regimen (≥ 2 months) or have been hospitalized for acute decompensated HF in the last 2 months
- Patients who are on experimental medications
- Patients who consume excessive alcohol (> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
- Patients who are pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of Thiamin deficiency as determined by Erythrocyte thiamin pyrophosphate (TPP) measured using a direct HPLC technique
Time Frame: baseline
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baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Eligible patients will be randomized to one of three commercially available doses of oral thiamin hydrochloride; 50 mg QD, 50 mg BID and 100 mg BID. They will take the supplements for 2 weeks.
Time Frame: baseline to after two weeks of supplementation
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baseline to after two weeks of supplementation
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Plasma samples will be analyzed for the plasma levels of NE, BNP, F2-isoprostanes
Time Frame: baseline and after supplementation
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baseline and after supplementation
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Urinary excretion of thiamin following the 2 week supplementation period.
Time Frame: by the end of two-week supplementation period
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by the end of two-week supplementation period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary Keith, PhD, RD, Unity Health Toronto
- Principal Investigator: Andrew Yan, MD, Cardiologist, St. Michael's Hospital
- Principal Investigator: Abdul Al-Hesayen, MD, Cardiologist, St. Michael's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 09-031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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