Dietary Supplements for COVID-19

NCT04780061 | Terminated Phase 3 Results DMC

• 1 other identifier: 20210072-01H
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

Natural Health Products; NHP; Dietary Supplements; Vitamin C; Vitamin D; Vitamin K; Zinc; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Participant-reported Overall Health

  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.

  During the intervention period (Daily for 21 days)

Secondary Outcomes (5)

• Effect of COVID-19 on the Health Status of Participants

  Baseline plus weeks 1, 2, 3, 4, 8, and 12

• Symptom Severity of Common COVID-19 Symptoms

  During the intervention period (Daily for 21 days)

• Total Symptom Duration

  During the intervention period (21 days)

• Incidence of Delayed Return to Usual Health

  12 weeks

• Number of Participants With a Hospital Visit or Admission

  12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Specific Product: Vitamin D3 50,000 IU Formulation: Capsule. Each capsule will contain 500 mg (50,000 units) cholecalciferol (vitamin D3) Dose: One capsule on day 1 of the intervention period Specific Product: Vitamin K2/D Formulation: Liquid. Each 0.0285 mL drop contains 30 mcg menaquinone-7 (MK-7, vitamin K2) and 3.125 mcg (125 units) cholecalciferol (vitamin D3). Dose: 0.114 mL (four drops) twice daily for 21 days totalling 240mcg MK-7 and 1,000 units cholecalciferol per day. Specific Product: Vitamin C/Zinc Formulation: Capsule. Each capsule will contain 666 mg ascorbic acid (vitamin C) and 8.3 mg of zinc acetate Dose: Three capsules three times daily for 21 days totalling 6 g ascorbic acid and 75 mg zinc acetate per day.

Drug: Vitamin D3 50,000 IU; Dietary Supplement: Vitamin C/Zinc; Dietary Supplement: Vitamin K2/D

Control

PLACEBO COMPARATOR

Specific Product: Vitamin D3 50,000 IU Placebo Equivalent: microcrystalline cellulose capsule, 350 mg Specific Product: Vitamin K2/D Placebo Equivalent: Medium chain triglyceride oil Specific Product: Vitamin C/Zinc Placebo Equivalent: microcrystalline cellulose capsule, 350 mg

Other: Microcrystalline Cellulose Capsule; Other: Medium Chain Triglyceride Oil

Interventions

Vitamin D3 50,000 IU DRUG

This is a loading dose of Vitamin D. Vitamin D (cholecalciferol \[vitamin D3\]) is a fat-soluble vitamin that is synthesized following ultraviolet radiation to the skin, naturally occurs in a few dietary sources and is available as a dietary supplement.

Also known as: Cholecalciferol

Treatment

Vitamin C/Zinc DIETARY_SUPPLEMENT

This is a combination of Vitamin C and Zinc. Vitamin C (ascorbic acid, ascorbate) is a water-soluble vitamin that naturally occurs in many foods and is sold as a dietary supplement. It is required for the functioning of several enzymes and is important for the immune system. Zinc is one of the most abundant essential trace elements in the human body and is required for the function of several hundred enzymes and transcription factors.

Treatment

Vitamin K2/D DIETARY_SUPPLEMENT

This is a combination of Vitamin K2 (menaquinone-7) and vitamin D. Vitamin K (menaquinone-7 \[vitamin K2\]) is a fat-soluble vitamin found in foods and sold as a dietary supplement. Vitamin K plays a large role in synthesizing coagulation factors in the blood, and vitamin K deficiency has been associated with uncontrolled bleeding. Vitamin K1 (phylloquinone) is an alternate form of vitamin K found in foods and supplements; however, vitamin K2 has a better absorption profile50 and additionally plays a role in bone metabolism controlling the binding of calcium, especially in older adults, where it attenuates the rate of bone loss

Treatment

Microcrystalline Cellulose Capsule OTHER

Placebo equivalent of Vitamin C/Zinc and Vitamin D3.

Control

Medium Chain Triglyceride Oil OTHER

Placebo equivalent of Vitamin K2/D

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18) who test positive for SARS-CoV-2 in an outpatient setting
• Access to internet

You may not qualify if:

• Symptom onset greater than 4 days prior to enrolment
• Supplementing regularly with \>500 mg vitamin C, \>1000 units vitamin D, \>120 mcg vitamin K (any form), or \>15 mg zinc taken daily within the past month
• Currently taking warfarin or an equivalent vitamin K antagonist anticoagulant
• End stage chronic kidney disease
• History of calcium oxalate kidney stones
• Active granulomatosis (sarcoidosis, tuberculosis, lymphoma)
• Known hypercalcemia or hypervitaminosis D
• Currently taking either of the following antibiotics: cephalexin, tetracyclines
• Participating in an investigational study or participation in an investigational study within the past 30 days
• Any reason which, under the discretion of the qualified investigator or delegate, would preclude the patient from participating.

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Ottawa Hospital Research Institute: collaborator
• Vitazan Professional: collaborator
• New Roots Herbal: collaborator

Study Sites (1)

The Centre for Health Innovation

Ottawa, Ontario, K2P0M7, Canada

Location

Related Publications (2)

• 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.

  PMID: 37739466 DERIVED

• 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.

  PMID: 35241474 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Early termination leading to small number of subjects analyzed; Symptom severity and duration questionnaire not validated

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Patterson Institute for Integrative Oncology Research

mlegacy@thechi.ca

6137921222

Study Officials

• Dugald Seely, ND, MSc

  Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

• Kumanan Wilson, MD, MSc

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: July 12, 2021
• Primary Completion: May 3, 2022
• Study Completion: July 7, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)