Heart Failure
Conditions
Keywords
Vitamin C supplementation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin C 500 mg
500 mg tablet taken orally with one meal daily
DIETARY_SUPPLEMENTVitamin C 1000 mg
1000 mg tablet taken orally with one meal daily
OTHERPlacebo
1 tablet taken orally with one meal daily
Sponsors
Sigma Theta Tau International Honor Society of Nursing
National Institute of Nursing Research (NINR)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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: * have undergone evaluation of HF and optimization of medical therapy, * vitamin C supplementation \<500 mg/day * have not been referred for heart transplantation, * able to read and speak English, * \>1 month from any inpatient hospitalization
Exclusion criteria
* history of renal stones or renal disease (serum creatinine \>1.5, * history of glucose-6-phosphate dehydrogenase deficiency (G6PD) and cognitive impairment that precludes giving informed consent or ability to follow protocol instructions * pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Vitamin C Level at Baseline | Baseline | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum |
| Serum Vitamin C Level at Month 3 | Month 3 | The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life Scores | Baseline and up to 3 months after enrollment | 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. |
| Total MSAS-HF Score | Baseline and up to 3 months after enrollment | 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. |
| Cardiac Function | Baseline and up to 3 months after enrollment | 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. |
| Oxidative Stress | Baseline and up to 3 months after enrollment | 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. |
Countries
United States
Participant flow
Pre-assignment details
Study briefly suspended due to administrative reasons.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 1 (500 mg) Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months | 12 |
| Intervention 2 (1000 mg) Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months | 12 |
| Control (Placebo) Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 1 |
| Overall Study | Study Suspended | 4 | 5 | 1 |
Baseline characteristics
| Characteristic | Intervention 1 (500 mg) | Intervention 2 (1000 mg) | Control (Placebo) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 11 Participants | 11 Participants | 30 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 18 | 51 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 8 | 54 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 8 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 4 Participants | 16 Participants |
| Region of Enrollment United States | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Serum Vitamin C Level at Baseline
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Time frame: Baseline
Population: Data unreported for participants who refused to provide blood sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention 1 (500 mg) | Serum Vitamin C Level at Baseline | 13372 ng/mL | Standard Deviation 11555 |
| Intervention 2 (1000 mg) | Serum Vitamin C Level at Baseline | 16079 ng/mL | Standard Deviation 12564 |
| Control (Placebo) | Serum Vitamin C Level at Baseline | 13111 ng/mL | Standard Deviation 9135 |
Primary
Serum Vitamin C Level at Month 3
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Time frame: Month 3
Population: Data unreported for participants who refused to provide blood sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention 1 (500 mg) | Serum Vitamin C Level at Month 3 | 21309 ng/mL | Standard Deviation 11740 |
| Intervention 2 (1000 mg) | Serum Vitamin C Level at Month 3 | 20574 ng/mL | Standard Deviation 13144 |
| Control (Placebo) | Serum Vitamin C Level at Month 3 | 12537 ng/mL | Standard Deviation 7945 |
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.
Time frame: Baseline and up to 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention 1 (500 mg) | Cardiac Function | Baseline | 6.9 L/min | — |
| Intervention 1 (500 mg) | Cardiac Function | Month 3 | 12.7 L/min | — |
| Control (Placebo) | Cardiac Function | Baseline | 5.6 L/min | Standard Deviation 5.1 |
| Control (Placebo) | Cardiac Function | Month 3 | 14.2 L/min | Standard Deviation 5.1 |
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.
Time frame: Baseline and up to 3 months after enrollment
Population: Data unreported for some participants due to study suspended and lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention 1 (500 mg) | Health Related Quality of Life Scores | Baseline | 45.3 score on a scale | Standard Deviation 32.2 |
| Intervention 1 (500 mg) | Health Related Quality of Life Scores | Month 3 | 68.2 score on a scale | Standard Deviation 23.2 |
| Intervention 2 (1000 mg) | Health Related Quality of Life Scores | Baseline | 31.4 score on a scale | Standard Deviation 24.7 |
| Intervention 2 (1000 mg) | Health Related Quality of Life Scores | Month 3 | 47.4 score on a scale | Standard Deviation 37.9 |
| Control (Placebo) | Health Related Quality of Life Scores | Baseline | 44.2 score on a scale | Standard Deviation 31.4 |
| Control (Placebo) | Health Related Quality of Life Scores | Month 3 | 27.6 score on a scale | Standard Deviation 27.6 |
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.
Time frame: Baseline and up to 3 months after enrollment
Population: Data unreported for participants who refused to provide blood sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention 1 (500 mg) | Oxidative Stress | Baseline | 23144 pg/mL | Standard Deviation 44504 |
| Intervention 1 (500 mg) | Oxidative Stress | 3 months | 507 pg/mL | Standard Deviation 262 |
| Intervention 2 (1000 mg) | Oxidative Stress | Baseline | 10406 pg/mL | Standard Deviation 27203 |
| Intervention 2 (1000 mg) | Oxidative Stress | 3 months | 2431 pg/mL | Standard Deviation 3753 |
| Control (Placebo) | Oxidative Stress | Baseline | 13832 pg/mL | Standard Deviation 20676 |
| Control (Placebo) | Oxidative Stress | 3 months | 2580 pg/mL | Standard Deviation 2667 |
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.
Time frame: Baseline and up to 3 months after enrollment
Population: Data unreported for some participants due to study suspended and lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention 1 (500 mg) | Total MSAS-HF Score | Baseline | 47.5 score on a scale | Standard Deviation 42.7 |
| Intervention 1 (500 mg) | Total MSAS-HF Score | Month 3 | 24.5 score on a scale | Standard Deviation 33.3 |
| Intervention 2 (1000 mg) | Total MSAS-HF Score | Month 3 | 24.8 score on a scale | Standard Deviation 41.4 |
| Intervention 2 (1000 mg) | Total MSAS-HF Score | Baseline | 20.2 score on a scale | Standard Deviation 26.6 |
| Control (Placebo) | Total MSAS-HF Score | Baseline | 31.2 score on a scale | Standard Deviation 26.8 |
| Control (Placebo) | Total MSAS-HF Score | Month 3 | 20.1 score on a scale | Standard Deviation 30 |