Trial record 7 of 1115 for:
Open Studies | micronutrients
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:
Phoenix VA Health Care System
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
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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 |
Dietary Supplement: 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 (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
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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)
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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: | November 17, 2011 |
| 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:
|
Micronutrients Trace Elements Heart Failure Ischemia Cardiomyopathies Heart Diseases |
Cardiovascular Diseases Pathologic Processes Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013