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

NCT01474486 | Completed Results DMC

• 1 other identifier: Parrington 005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Congestive Heart Failure; Ischemic Cardiomyopathy

Keywords

thiamin; pyridoxine; vitamin D; zinc; congestive heart failure (CHF); ischemic cardiomyopathy; nutritional injury; quality of life

Outcome Measures

Primary Outcomes (2)

• Change in Left Ventricular Ejection Fraction by Echocardiogram

  Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram. The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.

  Change from baseline in Left Ventricular Ejection Fraction at 6 months

• Change in Left Ventricular Ejection Fraction as Measured by Magnetic Resonance Imaging (MRI)

  Left Ventricular Ejection Fraction Measured by Magnetic Resonance Imaging (MRI). The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.

  Change from baseline in Left Ventricular Ejection Fraction at 6 months

Secondary Outcomes (6)

• Change in Quality of Life

  Change from baseline Quality of Life at 3 months

• Nutritional Status

  Change from baseline in nutritional status at 3 months

• Change in Quality of Life

  Change from baseline quality of life at 6 months

• Change on Quality of Life

  Change from baseline quality of life at 12 months

• Nutritional Status

  Change from baseline in nutritional status at 6 months

Study Arms (1)

Micronutrients

EXPERIMENTAL

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

Interventions

Micronutrients DRUG

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)

Also known as: ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride

Micronutrients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phoenix VA Health Care System: lead

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Micronutrients; Ergocalciferols; Thiamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Diane J. Parrington
• Organization: Phoenix VA Health Care System

diane.parrington@va.gov

602-277-5551

Study Officials

• Diane J Parrington, PhD

  Phoenix VA Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Associate Chief of Staff for Research

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: November 18, 2011
• Study Start: April 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 10, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)