Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Supplements for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 1, 2021
First Posted Date  ICMJE March 3, 2021
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE July 12, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
Participant-reported overall health [ Time Frame: During the intervention period (Daily for 21 days) ]
Difference in overall health measured using the EuroQol Visual Assessment Scale (EQ-VAS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • 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.
  • 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.
  • 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).
  • 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)
  • Frequency of Hospitalizations [ Time Frame: 12 weeks ]
    Includes ER visits, acute care admissions, and ICU admissions
  • Hospital Length of Stay [ Time Frame: 12 weeks ]
    Number of days in acute care or ICU
  • All-cause mortality [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • 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
  • 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.
  • 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).
  • 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)
  • Frequency of Hospitalizations [ Time Frame: 12 weeks ]
    Includes ER visits, acute care admissions, and ICU admissions
  • Hospital Length of Stay [ Time Frame: 12 weeks ]
    Number of days in acute care or ICU
  • All-cause mortality [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Supplements for COVID-19
Official Title  ICMJE Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
  • Other: Microcrystalline Cellulose Capsule
    Placebo equivalent of Vitamin C/Zinc and Vitamin D3.
  • Other: Medium Chain Triglyceride Oil
    Placebo equivalent of Vitamin K2/D
Study Arms  ICMJE
  • 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.

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

    Interventions:
    • Other: Microcrystalline Cellulose Capsule
    • Other: Medium Chain Triglyceride Oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Legacy, BSc 6137921222 ext 1 mlegacy@thechi.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04780061
Other Study ID Numbers  ICMJE 20210072-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Canadian College of Naturopathic Medicine
Study Sponsor  ICMJE The Canadian College of Naturopathic Medicine
Collaborators  ICMJE
  • Ottawa Hospital Research Institute
  • Vitazan Professional
  • New Roots Herbal
Investigators  ICMJE
Principal Investigator: Dugald Seely, ND, MSc Canadian College of Naturopathic Medicine
Principal Investigator: Kumanan Wilson, MD, MSc The Ottawa Hospital Research Institute
PRS Account The Canadian College of Naturopathic Medicine
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP