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

This study is currently recruiting participants.
Verified November 2011 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: November 17, 2011
Last verified: November 2011

January 28, 2011
November 17, 2011
April 2010
January 2013   (final data collection date for primary outcome measure)
Change in left ventricular ejection fraction (LVEF) between baseline and six months [ Time Frame: Change in LVEF between baseline and six months ] [ Designated as safety issue: No ]
LVEF will be measured using cardiac magnetic resonance imaging and strain echocardiogram
Same as current
Complete list of historical versions of study NCT01474486 on ClinicalTrials.gov Archive Site
  • Change in Quality of Life between baseline and six months [ Time Frame: Change in Quality of Life between baseline and six months ] [ Designated as safety issue: No ]
    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 ] [ 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 stutus include weight / anthropometrics, dietary/ alimentation, biochemical, clinical and drug.
Same as current
Not Provided
Not Provided
 
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)

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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Congestive Heart Failure
  • Ischemic Cardiomyopathy
Dietary Supplement: 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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • stable congestive heart failure (CHF) (three months without an exacerbation or major change in medication regimen) Stage B, C or D CHF resulting from ischemic cardiomyopathy with an ejection fraction ≤ 45%.

Exclusion Criteria:

  • recent (within the last three months) acute myocardial infarction or unstable angina, pacemaker or defibrillator or anticipated pacemaker or defibrillator placement in the next six months, 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, 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.
Both
18 Years to 89 Years
No
Contact: Diane J Parrington, PhD 6022775551 ext 17532 diane.parrington@va.gov
United States
 
NCT01474486
Parrington 005
Yes
Diane Parrington, Phoenix VA Health Care System
Phoenix VA Health Care System
Not Provided
Principal Investigator: Diane J Parrington, PhD Phoenix VA Health Care System
Phoenix VA Health Care System
November 2011

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