Trial Outcomes & Findings for Vitamin C Supplementation Intervention (NCT NCT04036110)

NCT ID: NCT04036110

Last Updated: 2021-03-09

Results Overview

The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-03-09

Participant Flow

Study briefly suspended due to administrative reasons.

Participant milestones

Measure	Intervention 1 (500 mg) Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Overall Study STARTED	12	12	12
Overall Study COMPLETED	5	5	10
Overall Study NOT COMPLETED	7	7	2

Reasons for withdrawal

Measure	Intervention 1 (500 mg) Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Overall Study Lost to Follow-up	3	2	1
Overall Study Study Suspended	4	5	1

Baseline Characteristics

Vitamin C Supplementation Intervention

Baseline characteristics by cohort

Measure	Intervention 1 (500 mg) n=12 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=12 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=12 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	54 years STANDARD_DEVIATION 18 • n=5 Participants	51 years STANDARD_DEVIATION 14 • n=7 Participants	56 years STANDARD_DEVIATION 8 • n=5 Participants	54 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data unreported for participants who refused to provide blood sample

The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

Outcome measures

Measure	Intervention 1 (500 mg) n=10 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=10 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=12 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Serum Vitamin C Level at Baseline	13372 ng/mL Standard Deviation 11555	16079 ng/mL Standard Deviation 12564	13111 ng/mL Standard Deviation 9135

PRIMARY outcome

Timeframe: Month 3

Population: Data unreported for participants who refused to provide blood sample

The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum

Outcome measures

Measure	Intervention 1 (500 mg) n=2 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=4 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=7 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Serum Vitamin C Level at Month 3	21309 ng/mL Standard Deviation 11740	20574 ng/mL Standard Deviation 13144	12537 ng/mL Standard Deviation 7945

SECONDARY outcome

Timeframe: Baseline and up to 3 months after enrollment

Population: Data unreported for some participants due to study suspended and lost to follow-up

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.

Outcome measures

Measure	Intervention 1 (500 mg) n=5 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=5 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=10 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Health Related Quality of Life Scores Baseline	45.3 score on a scale Standard Deviation 32.2	31.4 score on a scale Standard Deviation 24.7	44.2 score on a scale Standard Deviation 31.4
Health Related Quality of Life Scores Month 3	68.2 score on a scale Standard Deviation 23.2	47.4 score on a scale Standard Deviation 37.9	27.6 score on a scale Standard Deviation 27.6

SECONDARY outcome

Timeframe: Baseline and up to 3 months after enrollment

Population: Data unreported for some participants due to study suspended and lost to follow-up

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.

Outcome measures

Measure	Intervention 1 (500 mg) n=5 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=5 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=10 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Total MSAS-HF Score Baseline	47.5 score on a scale Standard Deviation 42.7	20.2 score on a scale Standard Deviation 26.6	31.2 score on a scale Standard Deviation 26.8
Total MSAS-HF Score Month 3	24.5 score on a scale Standard Deviation 33.3	24.8 score on a scale Standard Deviation 41.4	20.1 score on a scale Standard Deviation 30.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention 1 (500 mg) n=1 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=2 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Cardiac Function Baseline	6.9 L/min	—	5.6 L/min Standard Deviation 5.1
Cardiac Function Month 3	12.7 L/min	—	14.2 L/min Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline and up to 3 months after enrollment

Population: Data unreported for participants who refused to provide blood sample

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.

Outcome measures

Measure	Intervention 1 (500 mg) n=2 Participants Participants take vitamin C (L-Ascorbic acid) 500 mg tablet orally with one meal daily for 3 months	Intervention 2 (1000 mg) n=4 Participants Participants take vitamin C (L-Ascorbic acid) 1000 mg tablet orally with one meal daily for 3 months	Control (Placebo) n=7 Participants Participants take vitamin C placebo (Sugar pill) tablet orally with one meal daily for 3 months
Oxidative Stress 3 months	507 pg/mL Standard Deviation 262	2431 pg/mL Standard Deviation 3753	2580 pg/mL Standard Deviation 2667
Oxidative Stress Baseline	23144 pg/mL Standard Deviation 44504	10406 pg/mL Standard Deviation 27203	13832 pg/mL Standard Deviation 20676

Adverse Events

Intervention 1 (500 mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention 2 (1000 mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jia-Rong Wu, PhD, RN

University of North Carolina at Chapel Hill

Phone: 859-323-4712

Email: jiarong.wu2@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place