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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane J Parrington, PhD | Phoenix VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System | Phoenix | Arizona | 85012 | United States |
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40 participants consented to the study. Twelve were screen failures and six withdrew following consent but prior to their first visit when baseline data collection would have taken place and the intervention would have started. Therefore twenty-two participants received the intervention.
The participants served as their own control, so there is only one arm of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All individuals in whom either baseline or 6 month measures were obtained. | Posted | Least Squares Mean | Standard Error | Percent | Change from baseline in Left Ventricular Ejection Fraction at 6 months |
|
The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year.
The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micronutrients | Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All Cause Mortality | Cardiac disorders | Diagnoses | Systematic Assessment | CHF exacerbation following Non-ST segment elevation myocardial infarction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Metabolism and nutrition disorders | Diagnoses | Systematic Assessment | Abnormal lab value |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane J. Parrington | Phoenix VA Health Care System | 602-277-5551 | 7532 | diane.parrington@va.gov |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D004872 | Ergocalciferols |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
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Open Label
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| 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. | 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. | 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. | 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. | 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. | Change from baseline in nutritional status at 12 months |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Minnesota Living with Heart Failure Questionnaire | Total score on the Minnesota Living with Heart Failure Questionnaire. The scale is used to determine how much heart failure has affected life during the past month. There are 21 questions, each with 5 possible answers 0-5 where 0 is No or not applicable, and 1 is Very Little and 5 is Very Much. The lowest possible score is 0 and the highest possible score is 105. A low score indicates heart failure has little affect on quality of life and a high score indicates heart failure is negatively affecting quality of life. Participants completed the questionnaire during the research visits. | Median | Inter-Quartile Range | units on a scale |
|
| Serum vitamin B1 | Serum B1 or thiamin was measured in nmoL/L. The reference range was 78-185 nmoL/L. | Median | Inter-Quartile Range | nmoL/L |
|
| Serum B6 | Median | Inter-Quartile Range | ng/mL |
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| Serum Zinc | Median | Inter-Quartile Range | mcg/dL |
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| Serum Vitamin D | Median | Inter-Quartile Range | ng/mL |
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| Primary | 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. | All persons with at least one measurement of LVEF by MRI. | Posted | Least Squares Mean | Standard Error | Percent | Change from baseline in Left Ventricular Ejection Fraction at 6 months |
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| Secondary | 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. | All individuals with either baseline or 3 month measure of Quality of Life. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline Quality of Life at 3 months |
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| Secondary | 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. | All with both baseline and 3 month assessment of nutritional status | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline in nutritional status at 3 months |
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| Secondary | 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. | All individuals with either a baseline or six month measure of Quality of Life. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline quality of life at 6 months |
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| Secondary | 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. | All in whom either Baseline or 12 month Quality of Life was assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline quality of life at 12 months |
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| Secondary | 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. | All individuals with both baseline and 6 month assessment of nutritional status. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline in nutritional status at 6 months |
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| Secondary | 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. | All individuals with both baseline and 12 month assessments of nutritional status. | Posted | Median | Inter-Quartile Range | score on a scale | Change from baseline in nutritional status at 12 months |
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| 2 |
| 22 |
| 8 |
| 22 |
| 16 |
| 22 |
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| All cause mortality | Cardiac disorders | Diagnoses | Systematic Assessment | Admitted into and expired at community hospital. Cause is unknown. Participant had contacted the VA within 3 days of his death complaining of excessive dizziness. |
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| Serious Adverse Event | Cardiac disorders | Diagnoses | Systematic Assessment | Inpatient hospitalization for pain caused by ischemia of right lower extremity. Second hospitalization for bifemoral bypass of the right lower extremity. |
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| Serious Adverse Events | Infections and infestations | Diagnoses | Systematic Assessment | One inpatient hospitalization for wound dehiscence of L anterior ankle wound 9 months s/p L total ankle replacement. Second admission one month later for cellulitis of same area, followed by a 3rd hospitalization for same diagnoses 3 months later. |
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| Serious Adverse Event | Infections and infestations | Diagnoses | Systematic Assessment | Inpatient hospitalization for LLE cellulitis secondary to leg trauma. |
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| Adverse Events | Gastrointestinal disorders | Diagnoses | Systematic Assessment | Inpatient hospitalization for small bowel obstruction and ileus. |
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| Serious Adverse Event | Infections and infestations | Diagnoses | Systematic Assessment | Hospitalization for bacteremia from a urinary source. Also had an obstructing urethral stone. |
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| Serious Adverse Event | General disorders | Diagnoses | Systematic Assessment | Admitted for dehydration due to medication overuse. |
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| Serious Adverse Event | Blood and lymphatic system disorders | Diagnoses | Systematic Assessment | Hospital admission for uncontrolled bleeding and anemia after lacerating his arm. This is the same participant as described in #5. |
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| Serious Adverse Event | Vascular disorders | Diagnoses | Systematic Assessment | Hospitalized for a Left Lower Extremity femoral bypass graft thrombosis. This occurred between consent and starting the intervention and is the same participant at #2. |
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| Other | Gastrointestinal disorders | Diagnoses | Systematic Assessment | Diarrhea |
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| Other | Eye disorders | Diagnoses | Systematic Assessment | Conjunctivitis |
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| Other | General disorders | Diagnoses | Systematic Assessment | Flu-like symptoms |
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| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |