Vitamin D for 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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04536298 |
|
Recruitment Status :
Active, not recruiting
First Posted : September 2, 2020
Last Update Posted : January 27, 2023
|
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | August 27, 2020 | |||||||||
| First Posted Date ICMJE | September 2, 2020 | |||||||||
| Last Update Posted Date | January 27, 2023 | |||||||||
| Actual Study Start Date ICMJE | December 28, 2020 | |||||||||
| Estimated Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Rate of seeking healthcare visits (including hospitalizations, emergency room visits, or ambulatory or virtual clinician visits) for symptoms or concerns related to COVID-19 or deaths in participants newly diagnosed with COVID-19 (index cases) [ Time Frame: 4 weeks ] | |||||||||
| Original Primary Outcome Measures ICMJE |
Hospitalization or death in index cases [ Time Frame: 4 weeks ] | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
|
|||||||||
| Original Secondary Outcome Measures ICMJE |
|
|||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Vitamin D for COVID-19 Trial | |||||||||
| Official Title ICMJE | 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 | |||||||||
| Brief Summary | The Vitamin D for COVID-19 Trial (VIVID) is a randomized, placebo-controlled clinical trial in 2024 men and women from across the U.S. and Mongolia to investigate whether taking a daily dietary supplement of vitamin D vs. placebo for 4 weeks reduces the rate of seeking healthcare for symptoms or concerns related to COVID-19 in participants recently diagnosed with COVID-19, and reduces the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in household contacts of individuals with newly diagnosed COVID-19. | |||||||||
| Detailed Description | Data from laboratory studies, epidemiologic research, and randomized clinical trials conducted in the pre-COVID era strongly suggest that vitamin D is active in pathways relevant to immune function and may reduce the risk of acute respiratory infections. More recently, some observational studies have shown a significant association between low vitamin D status and worse clinical outcomes among COVID-19 patients. Whether vitamin D supplementation can reduce the risk of adverse clinical outcomes in recently diagnosed COVID-19 patients and/or reduce risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) in those likely to have been exposed to the virus (post-exposure prophylaxis) is unknown. The Vitamin D for COVID-19 Trial (VIVID) is a pragmatic, cluster-randomized clinical trial in 2024 men and women recruited nationwide from the U.S. and Mongolia. The trial is investigating whether taking a daily dietary supplement of vitamin D3 vs. placebo for 4 weeks reduces the rate of seeking healthcare visits (including hospitalizations, emergency room visits, or ambulatory or virtual clinician visits) for symptoms or concerns related to COVID-19 or deaths in people newly diagnosed with COVID-19, and reduces the risk of SARS-CoV-2 infection in household contacts of individuals with newly diagnosed COVID-19. The trial has enrolled 1747 individuals aged 18 or older who are newly diagnosed with COVID-19 ("index cases") and 277 household contacts aged 18 or older. Following receipt of informed consent, participants are randomized -- i.e., assigned by chance (like a coin toss) -- to one of two groups: (1) daily vitamin D3 (9600 IU/day on days 1-2; 3200 IU/day on days 3-28) or (2) daily vitamin D placebo. Index cases and household contacts of an index case (limited to at most one contact per household), if any, are assigned to the same group (cluster randomization). Participants take three oral softgel capsules on day 1, three capsules on day 2, and one capsule each day on days 3 through 28. Participants receive a 4-week supply of study capsules via overnight courier service. Participants fill out a short (15-20 minute) questionnaire each week during the 4-week pill-taking period, as well as a follow-up questionnaire at 8 weeks after randomization. These questionnaires ask about symptoms, general health, and use of medications and dietary supplements. Questionnaires are completed online using a secure Internet-based system known as the Research Electronic Data Capture (REDCap) system. Participants must have an e-mail address to enroll in the study. Occasionally, participants (or their delegates) may receive a telephone call from study staff to collect information or to clarify answers on the questionnaire. Participants may contact investigators or staff using a toll-free number, if they have any questions or need assistance. Participants (or their delegates) who indicate on a study questionnaire that they have been hospitalized are sent a medical release form to be signed and returned. The release form is used to get medical records from the participant's physician or hospital to confirm the specific reason for the hospitalization. In the event of a participant's death, the participant's delegate is sent a medical release form to be signed and returned. The release form is used to get medical records from the participant's physician or hospital to confirm the specific cause of death. Participants provide dried blood spot samples at baseline and week 4. Participants provide these samples using a sample collection kit mailed to their homes. Blood samples are collected through a finger prick onto a filter paper. Blood samples are stored and will be used to measure vitamin D (25(OH)D) levels. A subsample of participants provide follow-up dried blood spot samples at weeks 1, 2, or 3 to clarify the time course of 25(OH)D increase. In participants who are not diagnosed with COVID-19 during the study, blood samples will also be tested for COVID-19 antibodies. Support for VIVID is provided by Harvard University and private philanthropy. Tishcon Corporation (Salisbury, Maryland, USA) is donating the study capsules. The Karolinska Institute (Stockholm, Sweden) is donating the serology assessment. |
|||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
|||||||||
| Condition ICMJE | COVID-19 | |||||||||
| Intervention ICMJE |
|
|||||||||
| Study Arms ICMJE |
|
|||||||||
| Publications * |
|
|||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Actual Enrollment ICMJE |
2024 | |||||||||
| Original Estimated Enrollment ICMJE |
2700 | |||||||||
| Estimated Study Completion Date ICMJE | July 1, 2023 | |||||||||
| Estimated Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion/exclusion criteria for INDEX CASES: Inclusion criteria
Exclusion criteria
Inclusion/exclusion criteria for HOUSEHOLD CONTACTS: Inclusion criteria:
Exclusion criteria:
|
|||||||||
| Sex/Gender ICMJE |
|
|||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04536298 | |||||||||
| Other Study ID Numbers ICMJE | 2020P002815 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement ICMJE |
|
|||||||||
| Current Responsible Party | JoAnn E. Manson, MD, Brigham and Women's Hospital | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Brigham and Women's Hospital | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
|
|||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | Brigham and Women's Hospital | |||||||||
| Verification Date | January 2023 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||