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Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure

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ClinicalTrials.gov Identifier: NCT01474486
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Diane Parrington, Phoenix VA Health Care System

Tracking Information
First Submitted Date  ICMJE January 28, 2011
First Posted Date  ICMJE November 18, 2011
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Change in Left Ventricular Ejection Fraction [ Time Frame: Change from baseline in Left Ventricular Ejection Fraction at 6 months ]
Left Ventricular Ejection Fraction will be measured using cardiac magnetic resonance imaging and echocardiogram
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Change in left ventricular ejection fraction (LVEF) between baseline and six months [ Time Frame: Change in LVEF between baseline and six months ]
LVEF will be measured using cardiac magnetic resonance imaging and strain echocardiogram
Change History Complete list of historical versions of study NCT01474486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • Change in Quality of Life [ Time Frame: Change from baseline Quality of Life at 3 months ]
    The Minnesota Living with Heart Failure Questionnaire will be used to assess quality of life
  • Nutritional Status [ Time Frame: Change from baseline in nutritional status at 3 months ]
    Nutritional status will be determined using the Nine-Step Nutritional Care Process as developed by Dr. Mary Ann Kight. Axes of evidence to determine nutritional status include weight / anthropometrics, dietary/ alimentation, biochemical, clinical and drug.
  • Change in Quality of Life [ Time Frame: Change from baseline quality of life at 6 months ]
    The Minnesota Living with Heart Failure Questionnaire will used to assess quality of life.
  • Quality of Life [ Time Frame: Change from baseline quality of life at 12 months ]
    The Minnesota Living with Heart Failure Questionnaire will be used to assess quality of life.
  • Nutritional Status [ Time Frame: Change from baseline in nutritional status at 6 months ]
    Nutritional status will be determined using the Nine-Step Nutritional Care Process as developed by Dr. Mary Ann Kight. Axes of evidence to determine nutritional status include weight / anthropometrics, dietary/ alimentation, biochemical, clinical and drug.
  • Nutritional Status [ Time Frame: Change from baseline in nutritional status at 12 months ]
    Nutritional status will be determined using the Nine-Step Nutritional Care Process as developed by Dr. Mary Ann Kight. Axes of evidence to determine nutritional status include weight / anthropometrics, dietary/ alimentation, biochemical, clinical and drug.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
  • Change in Quality of Life between baseline and six months [ Time Frame: Change in Quality of Life between baseline and six months ]
    The Minnesota Living with Heart Failure Questionnaire will be used to assess quality of life at baseline, 3 months and 6 months
  • Change in nutritional status between baseline and six months [ Time Frame: Change in nutritional status between baseline and six months ]
    Nutritional status will be determined using the Nine-Step Nutritional Care Process as developed by Dr. Mary Ann Kight. Axes of evidence to determine nutritional stutus include weight / anthropometrics, dietary/ alimentation, biochemical, clinical and drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Official Title  ICMJE Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)
Brief Summary The purpose of this project is to conduct a preliminary test of the feasibility of a multi-micronutrient intervention to improve micronutrient status, cardiac function and quality of life in Veterans with Congestive Heart Failure (CHF).
Detailed Description Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction and an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure will be recruited. This is a one group study with Veterans serving as their own control. They will receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months. Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months and one year. Quality of life will be measured using the Minnesota Living with Heart Failure questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition focused physical examination and three days food records will also be measured at baseline, month 3, 6 and one year.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Other
Condition  ICMJE
  • Congestive Heart Failure
  • Ischemic Cardiomyopathy
Intervention  ICMJE Drug: Micronutrients
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Other Name: ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride
Study Arms  ICMJE Experimental: Micronutrients
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Intervention: Drug: Micronutrients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2011)
30
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • stable CHF (three months without an exacerbation or major change in medication regimen and cardiology provider determined medication regimen (angiotensin II receptor blockers (ARBs), aldosterone, angiotensin converting enzyme (ACE) inhibitors and Beta blockers) has been maximized), Stage B, C or D CHF resulting from ischemic cardiomyopathy with an ejection fraction ≤ 45% with or without a pacemaker or defibrillator . Potential participants who require further medication titration to attain maximal benefit, will need to wait 30 days after the provider has maximized the dose of medication to participate.

Exclusion Criteria:

  • recent (within the last three months) acute myocardial infarction, or unstable angina, pacemaker or defibrillator placed less than six months prior, or anticipated pacemaker or defibrillator placement in the next six months, or a bi ventricular pacemaker, corticosteroid use (> 20 mg Prednisone use or its equivalent per day > 2 weeks duration), isoniazid therapy, use of the study nutrition supplements at the study doses for the past month or longer,(if the participant has been taking a multivitamin or multivitamin with minerals , or other water soluble vitamins they will need to stop taking these for at least one month prior to initiating the study intervention), end-stage liver disease, end-stage renal disease requiring dialysis, receiving chemotherapy or radiation therapy, active alcohol/ substance abuse, pregnancy /lactation, women of childbearing potential who do not have medical documentation of surgically induced menopause, pancreatitis, any psychological issues like severe depression, claustrophobia, active problematic post-traumatic stress disorder (PTSD), or memory loss that prevents compliance with the supplement intake, agoraphobia which may interfere attendance at research visits or fear of needles which would limit their ability to have the blood tests completed, and any active eating disorders. Cardiac Magnetic Resonance Imaging (MRI) scan will not be used to test cardiac function in participants with a pacemaker or defibrillator. Nor will it be used for potential subjects with ferro magnetic materials (i.e., penile stimulator), inability to lie flat for up to one hour, inability to hold their breath for up to 15 seconds or those with claustrophobia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474486
Other Study ID Numbers  ICMJE Parrington 005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diane Parrington, Phoenix VA Health Care System
Study Sponsor  ICMJE Phoenix VA Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diane J Parrington, PhD Phoenix VA Health Care System
PRS Account Phoenix VA Health Care System
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP