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

Primary Purpose

Congestive Heart Failure, Ischemic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micronutrients
Sponsored by
Phoenix VA Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Congestive Heart Failure focused on measuring thiamin, pyridoxine, vitamin D, zinc, congestive heart failure (CHF), ischemic cardiomyopathy, nutritional injury, quality of life

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix VA Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micronutrients

Arm Description

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)

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Change in Quality of Life
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 -5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 3 months was calculated by subtracting the 3 month score from the baseline score. A lower score at 3 months indicates better QOL and a high score at 3 months indicates a worse QOL.
Nutritional Status
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 3 months.
Change in Quality of Life
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 6 months was calculated by subtracting the 6 month score from the baseline score. A lower score at 6 months indicates better QOL and a higher score at 6 months indicates a worse QOL.
Change on Quality of Life
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 12 months was calculated by subtracting the 12 month score from the baseline score. A lower score at 12 months indicates better QOL and a higher score at 12 months indicates a worse QOL.
Nutritional Status
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 6 months.
Nutritional Status
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 12 months.

Full Information

First Posted
January 28, 2011
Last Updated
May 26, 2021
Sponsor
Phoenix VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01474486
Brief Title
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Official Title
Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix VA Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Ischemic Cardiomyopathy
Keywords
thiamin, pyridoxine, vitamin D, zinc, congestive heart failure (CHF), ischemic cardiomyopathy, nutritional injury, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micronutrients
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Micronutrients
Other Intervention Name(s)
ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Left Ventricular Ejection Fraction by Echocardiogram
Description
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.
Time Frame
Change from baseline in Left Ventricular Ejection Fraction at 6 months
Title
Change in Left Ventricular Ejection Fraction as Measured by Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Change from baseline in Left Ventricular Ejection Fraction at 6 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 -5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 3 months was calculated by subtracting the 3 month score from the baseline score. A lower score at 3 months indicates better QOL and a high score at 3 months indicates a worse QOL.
Time Frame
Change from baseline Quality of Life at 3 months
Title
Nutritional Status
Description
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 3 months.
Time Frame
Change from baseline in nutritional status at 3 months
Title
Change in Quality of Life
Description
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 6 months was calculated by subtracting the 6 month score from the baseline score. A lower score at 6 months indicates better QOL and a higher score at 6 months indicates a worse QOL.
Time Frame
Change from baseline quality of life at 6 months
Title
Change on Quality of Life
Description
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 12 months was calculated by subtracting the 12 month score from the baseline score. A lower score at 12 months indicates better QOL and a higher score at 12 months indicates a worse QOL.
Time Frame
Change from baseline quality of life at 12 months
Title
Nutritional Status
Description
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 6 months.
Time Frame
Change from baseline in nutritional status at 6 months
Title
Nutritional Status
Description
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 12 months.
Time Frame
Change from baseline in nutritional status at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane J Parrington, PhD
Organizational Affiliation
Phoenix VA Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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