Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection

NCT04482673 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 00099939
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

Conditions

COVID-19; Vitamin D Deficiency; Respiratory Viral Infection

Keywords

COVID-19; Vitamin D Deficiency; Respiratory Viral Infection

Outcome Measures

Primary Outcomes (3)

• Change in total circulating 25(OH)D concentration

  metabolite of vitamin D

  monthly in COVID-19 negative participants through study completion for 1 year

• Change in total circulating 25(OH)D concentration in COVID-19 positives

  metabolite of vitamin D

  baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants

• Change in SARS-CoV-2 antibody titers

  The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.

  every 3 months up to 12 months

Secondary Outcomes (10)

• Change in inflammatory cytokine concentration (10 cytokine panel Elisa: Interferon (INF)-gamma, Interleukin (IL)-1beta, IL-2, IL-3, IL-4, IL-6, IL-8, IL-10, IL-13, Tumor Necrosis Factor (TNF)-alpha

  baseline and every 3 months up to 12 months

• Respiratory symptoms

  daily for 2 weeks

• Signs and symptoms of rhino/sinusitis

  Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positives

• NCI Dietary Intake

  baseline then at 6 and 12 months

• Charlson Comorbidity survey

  baseline then at 6 and 12 months

Study Arms (4)

COVID-19 Negative Active Treatment

EXPERIMENTAL

Participants will be randomized to vitamin D3 (6000 IU) per day for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Drug: Daily Vitamin D3

COVID-19 Negative Placebo

PLACEBO COMPARATOR

Participants in this arm would receive placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Drug: Daily placebo

COVID-19 Positive Active Treatment

EXPERIMENTAL

Participants will be randomized to vitamin D3 as a bolus (20,000 IU) per day for 3 days followed by high dose vitamin D (6000 IU) per dayfor 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Drug: Daily Vitamin D3; Drug: Bolus vitamin D3

COVID-19 Positive Placebo

PLACEBO COMPARATOR

Participants in this arm would receive placebo as a bolus followed by daily placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Drug: Daily placebo; Drug: Bolus placebo

Interventions

Daily Vitamin D3 DRUG

6000 IU vitamin D3 daily

Also known as: Daily cholecalciferol

COVID-19 Negative Active Treatment; COVID-19 Positive Active Treatment

Daily placebo DRUG

Placebo daily

COVID-19 Negative Placebo; COVID-19 Positive Placebo

Bolus vitamin D3 DRUG

Bolus 20,000 IU vitamin D3 daily for 3 days

Also known as: Bolus cholecalciferol

COVID-19 Positive Active Treatment

Bolus placebo DRUG

Bolus placebo daily for 3 days

COVID-19 Positive Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Hospitalization at the time of study recruitment.
• Any individual less than 50 years of age. The reason that the participants ≥50 years are being excluded from this study is because those who are ≥50 years have a higher risk of being symptomatic with COVID-19 and have the potential for the greatest benefit. The disease appears to manifest differently in children and its occurrence is quite rare.
• Only those patients tested for COVID-19 initially will be eligible to participate; therefore, anyone wanting to participate in the trial must have had a COVID-19 test prior to enrollment/participation in the study.
• Any individual who is not capable of making independent decisions and who is considered cognitively impaired.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Grassroots Health Nutrition Institute: collaborator
• ZRT Laboratory: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

COVID-19; Vitamin D Deficiency

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; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Carol L Wagner, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 22, 2020
• Study Start: July 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)