Dietary Supplements for COVID-19

Covid19 Clinical Trial

Official title:

Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04780061
• Other study ID #: 20210072-01H
• Status: Terminated
• Phase: Phase 3
• Start date: July 12, 2021
• Est. completion date: July 7, 2022

Study information

• Verified date: October 2022
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: July 7, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

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.
• 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.
• Medium Chain Triglyceride Oil
Placebo equivalent of Vitamin K2/D

Locations

Country	Name	City	State
Canada	The Centre for Health Innovation	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	New Roots Herbal, Ottawa Hospital Research Institute, Vitazan Professional

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During the intervention period (Daily for 21 days)
Secondary	Effect of COVID-19 on the health status of participants	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.	Baseline plus weeks 1, 2, 3, 4, 8, and 12
Secondary	Symptom Severity of common COVID-19 symptoms	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.	During the intervention period (Daily for 21 days)
Secondary	Total symptom duration	Measured as the time to a complete reduction of symptoms with no relapses (i.e., a 0 in all categories on the symptom questionnaire).	During the intervention period (21 days)
Secondary	Incidence of delayed return to usual health	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)	12 weeks
Secondary	Frequency of Hospitalizations	Includes ER visits, acute care admissions, and ICU admissions	12 weeks
Secondary	Hospital Length of Stay	Number of days in acute care or ICU	12 weeks
Secondary	All-cause mortality		12 weeks