Dietary Supplements for COVID-19

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

Interventions

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.

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute

  collaborator OTHER

• Vitazan Professional

  collaborator OTHER

• New Roots Herbal

  collaborator INDUSTRY

• The Canadian College of Naturopathic Medicine

  lead OTHER

Principal Investigators

• Dugald Seely, ND, MSc · Canadian College of Naturopathic Medicine

• Kumanan Wilson, MD, MSc · The Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-12

Primary Completion

2022-05-03

Completion

2022-07-07

Countries

• Canada

Study Locations