Vitamin D and COVID-19 Trial (VIVID)
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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 :
Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Dietary Supplement: vitamin D Dietary Supplement: Placebo | Phase 3 |

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 |
Estimated Study Start Date : | December 1, 2020 |
Estimated Primary Completion Date : | March 1, 2021 |
Estimated Study Completion Date : | March 1, 2021 |
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)
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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:
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Placebo Comparator: Placebo
Placebo
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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 |
- Hospitalization or death in index cases [ Time Frame: 4 weeks ]
- 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
- Time to hospitalization or death in index cases [ Time Frame: 4 weeks ]
- ICU admission/ventilation support in index cases [ Time Frame: 4 weeks ]
- SARS-CoV-2 infection in close household contacts [ Time Frame: 4 weeks ]
- 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

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.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion/exclusion criteria for INDEX CASES:
Inclusion criteria
- 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.
- 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.
- Ability and willingness to understand and provide informed consent.
Exclusion criteria
- Known current pregnancy.
- Current hospitalization.
- Unable to complete online questionnaires or adhere to study requirements.
- 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.
- Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity.
- Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy.
- Kidney failure or dialysis; severe liver disease or cirrhosis.
- Unstable, transient, or group (6 or more adults) living arrangement.
- Participation in other COVID-19 trials.
Inclusion/exclusion criteria for HOUSEHOLD CONTACTS:
Inclusion criteria:
- 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.
- Ability and willingness to understand and provide informed consent.
Exclusion criteria:
- Known current pregnancy.
- History of SARS-CoV-2 infection with onset of symptoms more than 6 days before study entry.
- Receipt of a SARS-CoV-2 vaccination or monoclonal antibody.
- Unable to complete online questionnaires or adhere to study requirements.
- 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.
- Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity.
- Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy or immunotherapy.
- Kidney failure or dialysis; severe liver disease or cirrhosis.
- Unstable, transient, or group (6 or more adults) living arrangement.
- Participation in other COVID-19 trials.

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
Contact: Trisha Copeland, MS, RD | 1-877-517-2555 | pcopeland2@bwh.harvard.edu |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02215 | |
Contact: Trisha Copeland, MS, RD 877-517-2555 pcopeland2@bwh.harvard.edu |
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 |
Responsible Party: | JoAnn E. Manson, MD, Professor of Medicine, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT04536298 |
Other Study ID Numbers: |
2020J-009152 |
First Posted: | September 2, 2020 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Details will be provided at a later date. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 SARS-CoV-2 infection coronavirus vitamin D hospitalization |
death disease severity treatment prevention |
Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |