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Vitamin D and COVID-19 Trial (VIVID)

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: NCT04536298
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Harvard Medical School
Harvard School of Public Health
Harvard Pilgrim Healthcare Institute
Fenway Health and Beth Israel Deaconess Medical Center
Tishcon Corporation
Takeda
Quest Diagnostics-Nichols Insitute
Karolinska Institutet
Philanthropic donations
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital

Brief Summary:
The Vitamin D and COVID-19 Trial (VIVID) is a nationwide randomized clinical trial in 2700 U.S. men and women to investigate whether taking a daily dietary supplement of vitamin D for 4 weeks reduces the risk of hospitalization and/or death in participants newly diagnosed with COVID-19, and reduces the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in their closest household contacts (as documented by seroconversion).

Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: vitamin D Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cluster-Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Vitamin D3 Supplementation to Reduce Disease Severity in Persons With Newly Diagnosed COVID-19 Infection and to Prevent Infection in Household Members
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Daily vitamin D3 (9600 IU/day on days 1 and 2; 3200 IU/day on days 3 through 28)
Dietary Supplement: vitamin D
Vitamin D softgel capsules; each capsule contains 3200 IU of vitamin D3. Three capsules per day (9600 IU/day) will be taken on days 1 and 2, and one capsule per day (3200 IU/day) will be taken on days 3 through 28
Other Names:
  • vitamin D3
  • cholecalciferol

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo softgel capsules. Three capsules per day will be taken on days 1 and 2, and one capsule per day will be taken on days 3 through 28




Primary Outcome Measures :
  1. Hospitalization or death in index cases [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Self-reported disease severity in index cases [ Time Frame: 4 weeks ]
    Severity: 1=no COVID-19 illness; 2=COVID-19 illness with no hospitalization; 3=COVID-19 illness with hospitalization or death

  2. Time to hospitalization or death in index cases [ Time Frame: 4 weeks ]
  3. ICU admission/ventilation support in index cases [ Time Frame: 4 weeks ]
  4. SARS-CoV-2 infection in close household contacts [ Time Frame: 4 weeks ]
  5. Self-reported disease severity in close household contacts [ Time Frame: 4 weeks ]
    Severity: 1=no COVID-19 illness; 2=COVID-19 illness with no hospitalization; 3=COVID-19 illness with hospitalization or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/exclusion criteria for INDEX CASES:

Inclusion criteria

  1. Adults aged 30 years or older who are newly diagnosed with COVID-19 infection within 72 hours of testing *AND* no more than 5 days from the onset of COVID-19-related symptoms.
  2. Age-specific criteria: Age 30 to 49 years with 2 or more comorbidities (diabetes; hypertension; body mass index of 30 or greater; chronic obstructive pulmonary disease or emphysema: history of heart attack, stroke, coronary bypass surgery, coronary angioplasty or stent, hospitalization for heart failure; diagnosed sleep apnea) and/or risk factors (smoking; African American, Hispanic, Native American) *OR* Age 50 to 59 years with 1 or more comorbidities or risk factors *OR* Age 60 or older regardless of comorbidity or risk factor status.
  3. Ability and willingness to understand and provide informed consent.

Exclusion criteria

  1. Known current pregnancy.
  2. Current hospitalization.
  3. Unable to complete online questionnaires or adhere to study requirements.
  4. Consume more than 400 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks.
  5. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity.
  6. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy.
  7. Kidney failure or dialysis; severe liver disease or cirrhosis.
  8. Unstable, transient, or group (6 or more adults) living arrangement.
  9. Participation in other COVID-19 trials.

Inclusion/exclusion criteria for HOUSEHOLD CONTACTS:

Inclusion criteria:

  1. Persons aged 18 years or older who live in the same household as the index case and have been identified as the closest contact within that household.
  2. Ability and willingness to understand and provide informed consent.

Exclusion criteria:

  1. Known current pregnancy.
  2. History of SARS-CoV-2 infection with onset of symptoms more than 6 days before study entry.
  3. Receipt of a SARS-CoV-2 vaccination or monoclonal antibody.
  4. Unable to complete online questionnaires or adhere to study requirements.
  5. Consume more than 400 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks.
  6. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity.
  7. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy or immunotherapy.
  8. Kidney failure or dialysis; severe liver disease or cirrhosis.
  9. Unstable, transient, or group (6 or more adults) living arrangement.
  10. Participation in other COVID-19 trials.

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): NCT04536298


Contacts
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Contact: Trisha Copeland, MS, RD 1-877-517-2555 pcopeland2@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Trisha Copeland, MS, RD    877-517-2555    pcopeland2@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Harvard School of Public Health
Harvard Pilgrim Healthcare Institute
Fenway Health and Beth Israel Deaconess Medical Center
Tishcon Corporation
Takeda
Quest Diagnostics-Nichols Insitute
Karolinska Institutet
Philanthropic donations
Investigators
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Principal Investigator: JoAnn E Manson, MD, DrPH Brigham and Women's Hospital
Principal Investigator: Rui Wang, PhD Harvard Medical School
Principal Investigator: Davaasambuu Ganmaa, PhD Harvard School of Public Health
Publications:
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Responsible Party: JoAnn E. Manson, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04536298    
Other Study ID Numbers: 2020P002815
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details will be provided at a later date.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JoAnn E. Manson, MD, Brigham and Women's Hospital:
COVID-19
SARS-CoV-2 infection
coronavirus
vitamin D
hospitalization
death
disease severity
treatment
prevention
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents