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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Phoenix VA Health Care System
Sponsor:
Information provided by (Responsible Party):
Diane Parrington, Phoenix VA Health Care System
ClinicalTrials.gov Identifier:
NCT01474486
First received: January 28, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Congestive Heart Failure
Ischemic Cardiomyopathy
Drug: Micronutrients

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)

Resource links provided by NLM:


Further study details as provided by Phoenix VA Health Care System:

Primary Outcome Measures:
  • Change in Left Ventricular Ejection Fraction [ Time Frame: Change from baseline in Left Ventricular Ejection Fraction at 6 months ] [ Designated as safety issue: No ]
    Left Ventricular Ejection Fraction will be measured using cardiac magnetic resonance imaging and echocardiogram


Secondary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Change from baseline Quality of Life at 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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: Zinc Sulfate, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474486

Contacts
Contact: Diane J Parrington, PhD 6022775551 ext 17532 diane.parrington@va.gov

Locations
United States, Arizona
Phoenix VA Health Care System Recruiting
Phoenix, Arizona, United States, 85012
Contact: Diane J Parrington, PhD    602-277-5551 ext 17532    diane.parrington@va.gov   
Principal Investigator: Diane J Parrington, PhD         
Sponsors and Collaborators
Phoenix VA Health Care System
Investigators
Principal Investigator: Diane J Parrington, PhD Phoenix VA Health Care System
  More Information

No publications provided

Responsible Party: Diane Parrington, Deputy Associate Chief of Staff for Research, Phoenix VA Health Care System
ClinicalTrials.gov Identifier: NCT01474486     History of Changes
Other Study ID Numbers: Parrington 005
Study First Received: January 28, 2011
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Phoenix VA Health Care System:
thiamin
pyridoxine
vitamin D
zinc
congestive heart failure (CHF)
ischemic cardiomyopathy
nutritional injury
quality of life

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ergocalciferols
Vitamin D
Pyridoxine
Thiamine
Vitamins
Zinc
Micronutrients
Vitamin B Complex
Trace Elements
Zinc Sulfate
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014