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Vitamin D for COVID-19 (VIVID Trial)
Phase 3
Waitlist Available
Led By Davaasambuu Ganmaa, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
VIVID Trial Summary
This trial is testing whether vitamin D supplements can reduce the rate of people seeking healthcare for symptoms related to COVID-19, and whether it can reduce the risk of infection with the virus in people who have been recently diagnosed with COVID-19.
Who is the study for?
The VIVID trial is for adults over 18 in the U.S. and Mongolia who've recently tested positive for COVID-19 or live with someone who has. Participants must not be in other COVID-19 trials, taking high doses of vitamin D, have severe kidney/liver disease, parathyroid conditions, take certain medications (for seizures/epilepsy), or have a history of hypercalcemia.Check my eligibility
What is being tested?
This study tests if daily vitamin D supplements can reduce healthcare visits related to COVID-19 symptoms and lower infection risk among household contacts compared to a placebo. It's randomized and placebo-controlled, meaning people are put into two groups by chance: one takes vitamin D and the other a dummy pill.See study design
What are the potential side effects?
Potential side effects from high doses of vitamin D may include elevated calcium levels leading to bone pain, digestive issues like nausea or constipation, fatigue, confusion, or heart rhythm problems. Placebo pills should not cause any direct side effects.
VIVID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
Disease severity in index cases
Disease symptom score in index cases
Long COVID symptoms in index cases
+3 moreVIVID Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Vitamin DActive Control1 Intervention
Daily vitamin D3 (9600 IU/day on days 1 and 2; 3200 IU/day on days 3 through 28)
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Find a Location
Who is running the clinical trial?
Tishcon CorporationUNKNOWN
Harvard Medical School (HMS and HSDM)OTHER
195 Previous Clinical Trials
1,314,021 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
7,861 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking part in other COVID-19 research studies.I am taking medication for seizures or epilepsy.I have high calcium levels or a sensitivity to vitamin D.I do not have severe kidney or liver disease.I am currently taking digoxin.I have had COVID-19 before.I have a condition affecting my parathyroid glands.I am over 18 and live with someone who is part of this study.You have taken more than 1000 IU of vitamin D per day from supplements in the last 4 weeks.I am 18 or older and was diagnosed with COVID-19 in the last 7 days.I am 18 or older, live with someone who recently tested positive for COVID-19, and can consent to participate.I have received a COVID-19 vaccine or monoclonal antibody treatment.I am currently in the hospital.I use vitamin D or calcium supplements over 1200 mg daily.I am currently receiving treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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