drugset / Trial / NCT04780061
Dietary Supplements for COVID-19
Phase 3
Terminated
90 enrolled
The Canadian College of Naturopathic Medicine
New Roots Herbal · collabOttawa Hospital Research Institute · collabVitazan Professional · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a double blind, placebo controlled, phase III randomized controlled trial evaluating the effects of the dietary supplements vitamin C, vitamin D, vitamin K, and zinc versus placebo on the overall health, symptom severity, and symptom duration of outpatients diagnosed with SARS-CoV-2.
Timeline
- Start
- 2021-07-12
- Primary completion
- 2022-05-03
- Completion
- 2022-07-07
Outcome
Missed primary endpoint
Stopped: “Public PCR testing stopped in Ontario”
registry analysis (superiority test); Treatment vs Control; p = 0.53; t-test, 2 sided NCT04780061 ↗
paper The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 PMID 37739466 ↗
Publications
- Seely D, Legacy M, Conte E, Keates C, Psihogios A, Ramsay T, Fergusson DA, Kanji S, Simmons JG, Wilson K. Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: a double-blind randomised controlled trial. BMJ Open. 2023 Sep 22;13(9):e073761. doi: 10.1136/bmjopen-2023-073761.
- Legacy M, Seely D, Conte E, Psihogios A, Ramsay T, Fergusson DA, Kanji S, Simmons JG, Wilson K. Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial. BMJ Open. 2022 Mar 3;12(3):e057024. doi: 10.1136/bmjopen-2021-057024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 1000 iu | — |