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| ID | Type | Description | Link |
|---|---|---|---|
| T32NR007091 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sigma Theta Tau International Honor Society of Nursing | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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This study is to test a low-cost, simple vitamin C supplementation intervention, that is, comparing placebo to 500 mg/day vitamin C and 1 gram/day vitamin C daily to assess feasibility and acceptability of vitamin C supplementation and effects on serum vitamin C level, health-related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function.
This study will address feasibility from the perspective of being able to: a) to detect significant differences in the serum vitamin C level after supplementation (3 months) between the intervention groups and the control group, b) to detect significant differences in health related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function after vitamin C supplementation (3 months) between the intervention groups and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Vitamin C 500 mg taken daily for 3 months |
|
| Intervention 2 | Experimental | Vitamin C 1000 mg taken daily for 3 months |
|
| Control | Placebo Comparator | Placebo tablets taken daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C 500 mg | Dietary Supplement | 500 mg tablet taken orally with one meal daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Vitamin C Level at Baseline | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Baseline |
| Serum Vitamin C Level at Month 3 | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life Scores | Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. The response scale for all 21 items on the MLHFQ is based on a 6-point (from 0 to 5). Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life. Measured at Baseline and Month 3. |
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Inclusion Criteria:
Patents recruited will have a diagnosis of chronic HF, either preserved or reduced ejection fraction. The diagnosis and etiology of chronic HF will be confirmed by a HF cardiologist using established criteria.
Other criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jia-Rong Wu, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNCH Meadowmont Clinic | Chapel Hill | North Carolina | 27517 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25360419 | Background | Carr AC, Vissers MC, Cook JS. The effect of intravenous vitamin C on cancer- and chemotherapy-related fatigue and quality of life. Front Oncol. 2014 Oct 16;4:283. doi: 10.3389/fonc.2014.00283. eCollection 2014. | |
| 11336107 | Background | Ellis GR, Anderson RA, Chirkov YY, Morris-Thurgood J, Jackson SK, Lewis MJ, Horowitz JD, Frenneaux MP. Acute effects of vitamin C on platelet responsiveness to nitric oxide donors and endothelial function in patients with chronic heart failure. J Cardiovasc Pharmacol. 2001 May;37(5):564-70. doi: 10.1097/00005344-200105000-00008. |
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All of the individual participant data collected during the trial will be shared, after de-identification.
Beginning 9 months and ending 36 months following article publication from this trial.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Study briefly suspended due to administrative reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention 1 (500 mg) | Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months |
| FG001 | Intervention 2 (1000 mg) | Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months |
| FG002 | Control (Placebo) | Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention 1 (500 mg) | Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months |
| BG001 | Intervention 2 (1000 mg) | Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months |
| 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 | Serum Vitamin C Level at Baseline | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Data unreported for participants who refused to provide blood sample | Posted | Mean | Standard Deviation | ng/mL | Baseline |
|
From Baseline through the end of study, an approximate total of 3 months
Per study protocol section 8, only pre-specified events and those events that are potentially related to participation in this research study must be collected.
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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 | Intervention 1 (500 mg) | Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jia-Rong Wu, PhD, RN | University of North Carolina at Chapel Hill | 859-323-4712 | jiarong.wu2@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2020 | Dec 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Vitamin C 1000 mg | Dietary Supplement | 1000 mg tablet taken orally with one meal daily |
|
|
| Placebo | Other | 1 tablet taken orally with one meal daily |
|
|
| Baseline and up to 3 months after enrollment |
| Total MSAS-HF Score | Symptom burden is measured using items from the Memorial Symptom Assessment Scale-Heart Failure (MSAS-HF). The MSAS-HF is an 8-item questionnaire to measure HF symptoms experienced by patients with HF. Patients will be first asked if the symptom was present during the previous 7 days. If present, three characteristics of each symptom will be rated: frequency of symptom, severity of symptom, and degree of symptom distress. Frequency is rated on a scale from 0 to 5 (1=no symptom to 5=all the time), severity rated on a scale from 0 to 5 (0=not at all to 5=extremely) and distress rated on a scale from 0 to 5 (0=not at all to 5=extremely). Burden score for each symptom can range from 0 (no burden) to 4 (greatest symptom frequency, severity, and distress). The total MAS-HF scores are summed to a range of 0-180, with higher scores indicating higher symptom burden. Measured at Baseline and Month 3. | Baseline and up to 3 months after enrollment |
| Cardiac Function | The MindWare Mobile impedance cardiograph (model number 50-2303-00) used to measure participant's cardiac function using the parameter of cardiac output. Measured at Baseline and Month 3. | Baseline and up to 3 months after enrollment |
| Oxidative Stress | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify 8-iso-PGF2a isoprostane in serum to reflect oxidative stress. Measured at Baseline and Month 3. | Baseline and up to 3 months after enrollment |
| BG002 | Control (Placebo) | Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control (Placebo) |
Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months |
|
|
| Primary | Serum Vitamin C Level at Month 3 | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum | Data unreported for participants who refused to provide blood sample | Posted | Mean | Standard Deviation | ng/mL | Month 3 |
|
|
|
| Secondary | Health Related Quality of Life Scores | Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. The response scale for all 21 items on the MLHFQ is based on a 6-point (from 0 to 5). Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life. Measured at Baseline and Month 3. | Data unreported for some participants due to study suspended and lost to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 3 months after enrollment |
|
|
|
| Secondary | Total MSAS-HF Score | Symptom burden is measured using items from the Memorial Symptom Assessment Scale-Heart Failure (MSAS-HF). The MSAS-HF is an 8-item questionnaire to measure HF symptoms experienced by patients with HF. Patients will be first asked if the symptom was present during the previous 7 days. If present, three characteristics of each symptom will be rated: frequency of symptom, severity of symptom, and degree of symptom distress. Frequency is rated on a scale from 0 to 5 (1=no symptom to 5=all the time), severity rated on a scale from 0 to 5 (0=not at all to 5=extremely) and distress rated on a scale from 0 to 5 (0=not at all to 5=extremely). Burden score for each symptom can range from 0 (no burden) to 4 (greatest symptom frequency, severity, and distress). The total MAS-HF scores are summed to a range of 0-180, with higher scores indicating higher symptom burden. Measured at Baseline and Month 3. | Data unreported for some participants due to study suspended and lost to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 3 months after enrollment |
|
|
|
| Secondary | Cardiac Function | The MindWare Mobile impedance cardiograph (model number 50-2303-00) used to measure participant's cardiac function using the parameter of cardiac output. Measured at Baseline and Month 3. | Data missing due to staff learning curve using the MindWare Mobile impedance cardiograph and technical problems to detect signal from participants with pacemaker devices which caused inability to measure impedance cardiograph. | Posted | Mean | Standard Deviation | L/min | Baseline and up to 3 months after enrollment |
|
|
|
| Secondary | Oxidative Stress | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify 8-iso-PGF2a isoprostane in serum to reflect oxidative stress. Measured at Baseline and Month 3. | Data unreported for participants who refused to provide blood sample | Posted | Mean | Standard Deviation | pg/mL | Baseline and up to 3 months after enrollment |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Intervention 2 (1000 mg) | Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Control (Placebo) | Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months | 0 | 12 | 0 | 12 | 0 | 12 |
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
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