The Prevalence of Thiamin Deficiency in Ambulatory Patients With Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00953823|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : December 24, 2012
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||110 participants|
|Official Title:||The Prevalence of Thiamin Deficiency in Ambulatory Patients With Heart Failure|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
- Prevalence of Thiamin deficiency as determined by Erythrocyte thiamin pyrophosphate (TPP) measured using a direct HPLC technique [ Time Frame: baseline ]
- 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 ]
- Plasma samples will be analyzed for the plasma levels of NE, BNP, F2-isoprostanes [ Time Frame: baseline and after supplementation ]
- Urinary excretion of thiamin following the 2 week supplementation period. [ Time Frame: by the end of two-week supplementation period ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953823
|St. Michael's Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Mary Keith, PhD, RD||St. Michael's Hospital, Toronto|
|Principal Investigator:||Andrew Yan, MD||Cardiologist, St. Michael's Hospital|
|Principal Investigator:||Abdul Al-Hesayen, MD||Cardiologist, St. Michael's Hospital|