Trial Outcomes & Findings for Dietary Supplements for COVID-19 (NCT NCT04780061)
NCT ID: NCT04780061
Last Updated: 2024-09-19
Results Overview
Measured using the EuroQol Visual Assessment Scale (EQ-VAS). Scores each day range from 0 (worst health imaginable) and 100 (best health imaginable). Scores summed over a 21-day period for a total range of 0-2100.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
During the intervention period (Daily for 21 days)
Results posted on
2024-09-19
Participant Flow
Participants were enrolled from outpatient COVID-19 test centres associated with The Ottawa Hospital. The primary site for enrolment and coordination of the study was The Centre for Health Innovation, Ottawa, Canada with support from the Ottawa Hospital Research Institute.
Participant milestones
| Measure |
Treatment
Vitamin C 6g Oral Daily x 21 Days; Vitamin D3 50,000 IU Oral x1; Vitamin D3 1,000 IU Oral Daily x 21 Days; Vitamin K2 240 mcg Oral Daily x 21 Days; Zinc Acetate 75mg Oral Daily x 21 Days;
|
Control
Placebo (Microcrystalline cellulose + medium chain triglyceride oil). Number of pills, frequency, and duration identical to treatment arm.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
|
Overall Study
Treated
|
42
|
44
|
|
Overall Study
COMPLETED
|
36
|
31
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
Reasons for withdrawal
| Measure |
Treatment
Vitamin C 6g Oral Daily x 21 Days; Vitamin D3 50,000 IU Oral x1; Vitamin D3 1,000 IU Oral Daily x 21 Days; Vitamin K2 240 mcg Oral Daily x 21 Days; Zinc Acetate 75mg Oral Daily x 21 Days;
|
Control
Placebo (Microcrystalline cellulose + medium chain triglyceride oil). Number of pills, frequency, and duration identical to treatment arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
Race data missing for 4 participants in the control arm
Baseline characteristics by cohort
| Measure |
Treatment
n=42 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=44 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
39.9 years
STANDARD_DEVIATION 14.9 • n=44 Participants
|
38.9 years
STANDARD_DEVIATION 13.8 • n=86 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=42 Participants
|
26 Participants
n=44 Participants
|
43 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=42 Participants
|
18 Participants
n=44 Participants
|
43 Participants
n=86 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
2 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
3 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
34 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
71 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
Latin American
|
1 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
0 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
1 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
Asian (South)
|
0 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
1 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
1 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
Asian (Southeast)
|
1 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
1 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
2 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
Asian (East)
|
0 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
2 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
2 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 Participants
n=42 Participants • Race data missing for 4 participants in the control arm
|
0 Participants
n=40 Participants • Race data missing for 4 participants in the control arm
|
2 Participants
n=82 Participants • Race data missing for 4 participants in the control arm
|
|
Vaccination Status
Received First Dose
|
41 Participants
n=42 Participants
|
42 Participants
n=44 Participants
|
83 Participants
n=86 Participants
|
|
Vaccination Status
Received Second Dose
|
41 Participants
n=42 Participants
|
42 Participants
n=44 Participants
|
83 Participants
n=86 Participants
|
|
Vaccination Status
Received Third Dose
|
37 Participants
n=42 Participants
|
30 Participants
n=44 Participants
|
67 Participants
n=86 Participants
|
|
Vaccination Status
Unvaccinated
|
1 Participants
n=42 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=86 Participants
|
|
Comorbidities
Hypertension
|
3 Participants
n=42 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=86 Participants
|
|
Comorbidities
Diabetes
|
0 Participants
n=42 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=86 Participants
|
|
Comorbidities
Coronary Artery Disease
|
0 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=86 Participants
|
|
Comorbidities
Asthma
|
7 Participants
n=42 Participants
|
9 Participants
n=44 Participants
|
16 Participants
n=86 Participants
|
|
Comorbidities
Chronic Kidney Disease
|
0 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=86 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disorder
|
0 Participants
n=42 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=86 Participants
|
|
Comorbidities
Liver Disease
|
0 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=86 Participants
|
|
Comorbidities
Cancer
|
0 Participants
n=42 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=86 Participants
|
|
Comorbidities
Immunodeficiency
|
0 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=86 Participants
|
|
Other Variables
Smoking History
|
7 Participants
n=42 Participants
|
8 Participants
n=44 Participants
|
15 Participants
n=86 Participants
|
|
Other Variables
Symptoms at Testing
|
38 Participants
n=42 Participants
|
36 Participants
n=44 Participants
|
74 Participants
n=86 Participants
|
PRIMARY outcome
Timeframe: During the intervention period (Daily for 21 days)Population: Participants were included in the analysis of overall health, symptom severity, and symptom duration if they completed the 21-day intervention period, completed at least 11 (52%) daily assessments, and did not miss more than 3 assessments sequentially
Measured using the EuroQol Visual Assessment Scale (EQ-VAS). Scores each day range from 0 (worst health imaginable) and 100 (best health imaginable). Scores summed over a 21-day period for a total range of 0-2100.
Outcome measures
| Measure |
Treatment
n=34 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=24 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Participant-reported Overall Health
|
1790 score on a scale
Standard Deviation 226.6
|
1752.6 score on a scale
Standard Deviation 220.7
|
SECONDARY outcome
Timeframe: Baseline plus weeks 1, 2, 3, 4, 8, and 12Population: Participants were included in this analysis if they completed a baseline questionnaire.
Measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Scores are converted into a unique health state. Health states are converted to an index value between 0 and 1, where 1 is considered the best possible health and 0 is the worst possible health.
Outcome measures
| Measure |
Treatment
n=41 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=40 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Effect of COVID-19 on the Health Status of Participants
Week 8
|
0.95 score on a scale
Standard Deviation 0.08
|
0.95 score on a scale
Standard Deviation 0.09
|
|
Effect of COVID-19 on the Health Status of Participants
Baseline
|
0.88 score on a scale
Standard Deviation 0.1
|
0.88 score on a scale
Standard Deviation 0.12
|
|
Effect of COVID-19 on the Health Status of Participants
Week 1
|
0.95 score on a scale
Standard Deviation 0.08
|
0.93 score on a scale
Standard Deviation 0.1
|
|
Effect of COVID-19 on the Health Status of Participants
Week 2
|
0.95 score on a scale
Standard Deviation 0.07
|
0.94 score on a scale
Standard Deviation 0.09
|
|
Effect of COVID-19 on the Health Status of Participants
Week 3
|
0.94 score on a scale
Standard Deviation 0.08
|
0.91 score on a scale
Standard Deviation 0.1
|
|
Effect of COVID-19 on the Health Status of Participants
Week 4
|
0.96 score on a scale
Standard Deviation 0.08
|
0.97 score on a scale
Standard Deviation 0.05
|
|
Effect of COVID-19 on the Health Status of Participants
Week 12
|
0.96 score on a scale
Standard Deviation 0.07
|
0.96 score on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: During the intervention period (Daily for 21 days)Population: Participants were included in this analysis if they completed the 21-day intervention period, completed at least 11 (52%) daily assessments, and did not miss more than 3 assessments sequentially.
Measured using an internally-developed questionnaire. Includes fever, cough, shortness of breath, fatigue, headache, myalgia/arthralgia, nausea, vomiting, diarrhea, congestion, loss of taste, and loss of smell. Scores range from 0-3 for each symptom, totaling 0-42 for each day. 0 = no symptom, 1 = mild symptom, 2 = moderate symptom, 3 = severe symptom. Scores converted into a number out of 100 and summed over 21 days for a range of 0-2100 where a higher score indicates a higher symptom severity (i.e., a worse outcome).
Outcome measures
| Measure |
Treatment
n=34 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=24 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Symptom Severity of Common COVID-19 Symptoms
|
166.3 score on a scale
Standard Deviation 92.3
|
192.9 score on a scale
Standard Deviation 153.6
|
SECONDARY outcome
Timeframe: During the intervention period (21 days)Population: Participants were included in this analysis if they completed the 21-day intervention period, completed at least 11 (52%) daily assessments, and did not miss more than 3 assessments sequentially.
Measured as the time to a complete reduction of symptoms with no relapses (i.e., a 0 in all categories on the symptom questionnaire).
Outcome measures
| Measure |
Treatment
n=34 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=24 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Total Symptom Duration
|
13.0 Days
Interval 0.0 to 21.0
|
12.5 Days
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants were included in this analysis if they completed 12 weeks of follow-up.
Measured by the number of people experiencing "ongoing symptomatic COVID-19" (symptoms persisting between 4 and 12 weeks) and the number of people experiencing "post-COVID-19 syndrome" (symptoms persisting at least 12 weeks)
Outcome measures
| Measure |
Treatment
n=35 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=28 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Incidence of Delayed Return to Usual Health
Ongoing Symptomatic COVID-19
|
6 Participants
|
5 Participants
|
|
Incidence of Delayed Return to Usual Health
Post COVID-19 Syndrome
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who started the study drug were included in this analysis
Includes ER visits, acute care admissions, and ICU admissions
Outcome measures
| Measure |
Treatment
n=42 Participants
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=44 Participants
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Number of Participants With a Hospital Visit or Admission
Intensive Care Unit Admissions
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Hospital Visit or Admission
Emergency Room Visits
|
2 Participants
|
4 Participants
|
|
Number of Participants With a Hospital Visit or Admission
Acute Care Admissions
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=44 participants at risk
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=46 participants at risk
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/44 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
2.2%
1/46 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
Other adverse events
| Measure |
Treatment
n=44 participants at risk
Vitamin C, Vitamin D3, Vitamin K2, Zinc
|
Control
n=46 participants at risk
Placebo (Microcrystalline cellulose + medium chain triglyceride oil)
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/44 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
2.2%
1/46 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
2/44 • Number of events 2 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
4.3%
2/46 • Number of events 2 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
2.2%
1/46 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/44 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
2.2%
1/46 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Nausea
|
18.2%
8/44 • Number of events 8 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
2.2%
1/46 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Heartburn
|
2.3%
1/44 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
0.00%
0/46 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Bloating
|
4.5%
2/44 • Number of events 2 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
0.00%
0/46 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
2.3%
1/44 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
0.00%
0/46 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/44 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
0.00%
0/46 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/44 • Number of events 1 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
0.00%
0/46 • During the intervention period (21 days) plus 1 additional week (4 weeks total)
|
Additional Information
Clinical Trial Coordinator
Patterson Institute for Integrative Oncology Research
Phone: 6137921222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place