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Dietary Supplements for COVID-19

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ClinicalTrials.gov Identifier: NCT04780061
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborators:
Ottawa Hospital Research Institute
Vitazan Professional
New Roots Herbal
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Vitamin D3 50,000 IU Dietary Supplement: Vitamin C/Zinc Dietary Supplement: Vitamin K2/D Other: Microcrystalline Cellulose Capsule Other: Medium Chain Triglyceride Oil Phase 3

Detailed Description:

This study proposed is a double-blind, placebo-controlled, phase III randomized controlled trial powered to detect meaningful differences in the overall health and symptom severity of people with COVID-19 between the treatment and control arms. Eligible participants will be randomly assigned, using a web randomization system, in a ratio of 1:1 to one of the following groups: (1) nutrient therapy with vitamin D, vitamin C, vitamin K2, and zinc or (2) placebo. Total trial duration will be 12 weeks. Nutrients or placebo will be given for a period of 21 days following enrolment and randomization. Total trial duration will be 12 weeks. Adverse events will be collected during the treatment phase plus one additional week (maximum 4 weeks).

With respect to the primary outcome of participant-reported overall health, power calculations were conducted based on between-group differences at a single time point (21 days) and Cohen's guideline for a small effect size of 0.3. A sample size of 176 (88 per arm) provides 80% power to detect a difference at an α of 0.05. To account for an approximate 10-15% lost to follow-up we will enrol 200 participants (100 per arm).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment

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
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.
Other Name: Cholecalciferol

Dietary Supplement: Vitamin C/Zinc
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.

Dietary Supplement: Vitamin K2/D
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

Placebo Comparator: Control

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
Placebo equivalent of Vitamin C/Zinc and Vitamin D3.

Other: Medium Chain Triglyceride Oil
Placebo equivalent of Vitamin K2/D




Primary Outcome Measures :
  1. Participant-reported overall health [ Time Frame: During the intervention period (Daily for 21 days) ]
    Measured using the EuroQol Visual Assessment Scale (EQ-VAS). Scores each day range from 0 (worst health imaginable) and 100 (best health imaginable).


Secondary Outcome Measures :
  1. Effect of COVID-19 on the health status of participants [ Time Frame: Baseline plus weeks 1, 2, 3, 4, 8, and 12 ]
    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.

  2. Symptom Severity of common COVID-19 symptoms [ Time Frame: During the intervention period (Daily for 21 days) ]
    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.

  3. Total symptom duration [ Time Frame: During the intervention period (21 days) ]
    Measured as the time to a complete reduction of symptoms with no relapses (i.e., a 0 in all categories on the symptom questionnaire).

  4. Incidence of delayed return to usual health [ Time Frame: 12 weeks ]
    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 longer than 12 weeks)

  5. Frequency of Hospitalizations [ Time Frame: 12 weeks ]
    Includes ER visits, acute care admissions, and ICU admissions

  6. Hospital Length of Stay [ Time Frame: 12 weeks ]
    Number of days in acute care or ICU

  7. All-cause mortality [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Symptom onset greater than 4 days prior to enrolment
  2. 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
  3. Currently taking warfarin or an equivalent vitamin K antagonist anticoagulant
  4. End stage chronic kidney disease
  5. History of calcium oxalate kidney stones
  6. Active granulomatosis (sarcoidosis, tuberculosis, lymphoma)
  7. Known hypercalcemia or hypervitaminosis D
  8. Currently taking either of the following antibiotics: cephalexin, tetracyclines
  9. Participating in an investigational study or participation in an investigational study within the past 30 days
  10. Any reason which, under the discretion of the qualified investigator or delegate, would preclude the patient from participating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780061


Contacts
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Contact: Mark Legacy, BSc 6137921222 ext 1 mlegacy@thechi.ca

Locations
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Canada, Ontario
The Centre for Health Innovation Recruiting
Ottawa, Ontario, Canada, K2P0M7
Contact: Mark Legacy, BSc    6137921222 ext 1    mlegacy@thechi.ca   
Sub-Investigator: Ellen Conte, ND         
Sub-Investigator: Athanasios Psihogios, ND (Inactive)         
Sub-Investigator: Dean Fergusson, PhD         
Sub-Investigator: Tim Ramsay, PhD         
Sub-Investigator: Salmaan Kanji, BSc, PharmD         
Sub-Investigator: Graydon Simmons, MD         
Sub-Investigator: Mark Legacy, BSc         
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Ottawa Hospital Research Institute
Vitazan Professional
New Roots Herbal
Investigators
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Principal Investigator: Dugald Seely, ND, MSc Canadian College of Naturopathic Medicine
Principal Investigator: Kumanan Wilson, MD, MSc The Ottawa Hospital Research Institute
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Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT04780061    
Other Study ID Numbers: 20210072-01H
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Canadian College of Naturopathic Medicine:
Natural Health Products
NHP
Dietary Supplements
Vitamin C
Vitamin D
Vitamin K
Zinc
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Vitamin K
Vitamin K 2
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants