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Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection (VitD-COVID19)

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: NCT04482673
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Grassroots Health Nutrition Institute
ZRT Laboratory
Information provided by (Responsible Party):
Carol L. Wagner, MD, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
COVID-19 Vitamin D Deficiency Respiratory Viral Infection Drug: Daily Vitamin D3 Drug: Daily placebo Drug: Bolus vitamin D3 Drug: Bolus placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Vitamin D in Mitigating COVID-19 Infection Severity: Focusing on Reducing Health Disparities in South Carolina
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: COVID-19 Negative Active Treatment
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
6000 IU vitamin D3 daily
Other Name: Daily cholecalciferol

Placebo Comparator: COVID-19 Negative Placebo
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
Placebo daily

Experimental: COVID-19 Positive Active Treatment
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
6000 IU vitamin D3 daily
Other Name: Daily cholecalciferol

Drug: Bolus vitamin D3
Bolus 20,000 IU vitamin D3 daily for 3 days
Other Name: Bolus cholecalciferol

Placebo Comparator: COVID-19 Positive Placebo
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
Placebo daily

Drug: Bolus placebo
Bolus placebo daily for 3 days




Primary Outcome Measures :
  1. Change in total circulating 25(OH)D concentration [ Time Frame: monthly in COVID-19 negative participants through study completion for 1 year ]
    metabolite of vitamin D

  2. Change in total circulating 25(OH)D concentration in COVID-19 positives [ Time Frame: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants ]
    metabolite of vitamin D

  3. Change in SARS-CoV-2 antibody titers [ Time Frame: every 3 months up to 12 months ]
    The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.


Secondary Outcome Measures :
  1. 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 [ Time Frame: baseline and every 3 months up to 12 months ]
    At baseline, 3, 6, 9 and 12 months, inflammatory cytokines will be measured in participant plasma samples. Cytokines to be measured are Interferon-gamma (IFN-g), Interleukin-1beta (IL-1B), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13, and Tumor Necrosis Factor-alpha (TNFa). Values of these cytokines at baseline will compared to those at 3, 6, 9, and 12 months

  2. Respiratory symptoms [ Time Frame: daily for 2 weeks ]
    COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks

  3. Signs and symptoms of rhino/sinusitis [ Time Frame: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positives ]
    Inventory of signs and symptoms of rhino/sinusitis. These signs include sneezing, running nose, cough, dizziness, fatigue, and sense of smell. Each sign is rated on a scale of 0 to 5, with 0 indicating not problem, for instance 1 indicating mild problem, 4 indicating severe problem and 5 indicating problem as bad as it can be.

  4. NCI Dietary Intake [ Time Frame: baseline then at 6 and 12 months ]
    Dietary intake assessment

  5. Charlson Comorbidity survey [ Time Frame: baseline then at 6 and 12 months ]
    Survey of participant health problems

  6. Paffenberger Physical Activity Assessment [ Time Frame: Baseline then at 6 and 12 months ]
    Assessment of physical activity of each participant

  7. Perceived stress [ Time Frame: monthly for 1 year ]
    Each participant will complete the Perceived Stress Scale Questionnaire (PSS) to assess their perceived stress. Assessments are base on a scale of 0 to 4, with 0 indicating "never" and 4 indicating "very often"

  8. Pandemic stress [ Time Frame: monthly for 1 year ]
    Each participant will complete the and Pandemic Stress Index Questionnaire (PSI) to assess their perceived stress cause by the pandemic. Assessments are base on a scale of 0 to 6, with 0 indicating "not at all" and 5 indicating "extremely," and 6 indicating "decline to answer."

  9. NEO-Personality Inventory [ Time Frame: baseline visit ]
    Personality characteristics of each participant

  10. GrassrootsHealth Monthly Health assessment [ Time Frame: baseline, 6, and 12 months ]
    A health assessment will be completed by each participant monthly for 1year. This health. This is for information on health status only and not for comparative assessment.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Entry Criteria:

---Adults aged 50 years of age or older who presents to MUSC or its affiliate hospitals (or associated testing centers) for COVID-19 testing during the recruitment period is eligible for participation.

Exclusion Criteria:

  • 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.

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): NCT04482673


Contacts
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Contact: Carol L Wagner, MD 843-792-8829 washinro@musc.edu
Contact: Renee O Washington, MS 8437925884 washinro@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Carol L Wagner, MD    843-792-8829    wagnercl@musc.edu   
Contact: Renee O Washington, MS    843-792-5884    washinro@musc.edu   
Principal Investigator: Carol L Wagner, MD         
Sub-Investigator: John E Baatz, PhD         
Sub-Investigator: Jeffrey Korte, PhD         
Sub-Investigator: Carole Baggerly         
Sponsors and Collaborators
Medical University of South Carolina
Grassroots Health Nutrition Institute
ZRT Laboratory
Investigators
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Principal Investigator: Carol L Wagner, MD Medical University of South Carolina
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Responsible Party: Carol L. Wagner, MD, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04482673    
Other Study ID Numbers: 00099939
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol L. Wagner, MD, Medical University of South Carolina:
COVID-19
Vitamin D Deficiency
Respiratory Viral Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents