Congestive Heart FailureNCT01474486
Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
A study testing Micronutrients in people with Congestive Heart Failure and Ischemic Cardiomyopathy, run by Phoenix VA Health Care System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Congestive Heart Failure, Ischemic Cardiomyopathy
- What is being tested?
- Micronutrients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System
Phoenix, Arizona, 85012
About this study
Official title: 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).
Read the 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.
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy
- Being tested
- Micronutrients
- Keywords
- thiamin, pyridoxine, vitamin D, zinc, congestive heart failure (CHF), ischemic cardiomyopathy, nutritional injury, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronutrientsDrug
Also called ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin Hydrochloride
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Micronutrients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline in Left Ventricular Ejection Fraction at 6 months
Secondary outcomes (6)
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.
Measured: Change from baseline Quality of Life at 3 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 3 months.
Measured: Change from baseline in nutritional status 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.
Measured: Change from baseline quality of life at 6 months
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.
Measured: Change from baseline quality of life at 12 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 6 months.
Measured: Change from baseline in nutritional status 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.
Measured: Change from baseline in nutritional status at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Diane Parrington, Phoenix VA Health Care System
- Investigators
- Diane J Parrington, PhD, Principal investigator, Phoenix VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474486
- Sponsor's protocol ID
- Parrington 005
- Status last verified
- May 2021
- First submitted
- 28 Jan 2011
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Multi-Micronutrient Intervention as a Palliative Care Therapy in Patients With Congestive Heart Failure(CHF)
- ClinicalTrials.gov ID
- NCT01474486
- Acronym / sponsor ID
- Parrington 005
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy
- Keywords
- thiamin, pyridoxine, vitamin D, zinc, congestive heart failure (CHF), ischemic cardiomyopathy, nutritional injury, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Study start
- Apr 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micronutrients | Experimental | Drug: MicronutrientsThiamin 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) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicronutrientsAlso: ZnSO4, Vitamin B50, Ergocalciferol, & Thiamin HydrochlorideThiamin 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 |
Primary outcome
Change in Left Ventricular Ejection Fraction by Echocardiogram
Time frame: Change from baseline in Left Ventricular Ejection Fraction at 6 months
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)
Time frame: Change from baseline in Left Ventricular Ejection Fraction at 6 months
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.
6 secondary outcomes
Change in Quality of Life
Time frame: Change from baseline Quality of Life at 3 months
Nutritional Status
Time frame: Change from baseline in nutritional status at 3 months
Change in Quality of Life
Time frame: Change from baseline quality of life at 6 months
Change on Quality of Life
Time frame: Change from baseline quality of life at 12 months
Nutritional Status
Time frame: Change from baseline in nutritional status at 6 months
Nutritional Status
Time frame: Change from baseline in nutritional status at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane J Parrington, PhD principal investigator
Phoenix VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrients in people with Congestive Heart Failure and Ischemic Cardiomyopathy, run by Phoenix VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction by Echocardiogram (time frame: Change from baseline in Left Ventricular Ejection Fraction at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.