Vitamin D for COVID-19 Trial

NCT04536298 | Completed Phase 3 DMC

• 1 other identifier: 2020P002815
• Study Type: interventional
• Target: 2,024
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2 infection; coronavirus; vitamin D; hospitalization; death; disease severity; treatment; prevention

Outcome Measures

Primary Outcomes (1)

• 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)

  4 weeks

Secondary Outcomes (6)

• Rate of in-person healthcare visits related to COVID-19 infection among index cases

  4 weeks

• Disease symptom score in index cases

  4 weeks

• Disease severity in index cases

  4 weeks

• Time to seeking healthcare (including hospitalizations, emergency room visits, or ambulatory or other clinician visits) or death in index cases

  4 weeks

• SARS-CoV-2 infection in close household contacts

  4 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Daily vitamin D3 (9600 IU/day on days 1 and 2; 3200 IU/day on days 3 through 28)

Dietary Supplement: vitamin D

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

vitamin D DIETARY_SUPPLEMENT

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

Also known as: vitamin D3, cholecalciferol

Vitamin D

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Adults aged 18 years or older who are newly diagnosed with COVID-19 infection within 7 days of testing.
• Ability and willingness to understand and provide informed consent.
• Known current pregnancy.
• Current hospitalization.
• Unable to complete online questionnaires or adhere to study requirements.
• Consume more than 1000 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.
• Use of prescription vitamin D treatments (Calcitriol \[Rocaltrol, Calcitrol, Vectical, Calcijex\] or Paricalcitol \[Zemplar\]).
• Consume supplements with more than 1200 mg calcium per day.
• 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.
• Any parathyroid conditions.
• Use of medications for seizures or epilepsy. Examples: Carbamazepine (Carbatrol, Tegretol), Phenytoin (Dilantin, Phenytek), Valproic acid (Depakene), Oxcarbazepine (Oxtellar, Trileptal), Phenobarbital, Topiramate (Topamax).
• Use of digoxin.
• Inability to receive an overnight express mail shipment of study pills at a home address.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Harvard School of Public Health (HSPH): collaborator
• Fenway Health and Beth Israel Deaconess Medical Center: collaborator
• Tishcon Corporation: collaborator
• Takeda: collaborator
• Quest Diagnostics-Nichols Insitute: collaborator
• Laboratory Corporation of America: collaborator
• Trialfacts: collaborator
• Karolinska Institutet: collaborator
• Philanthropic donations: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Manson JE, Bassuk SS. Commentary. Eliminating vitamin D deficiency during the COVID-19 pandemic: A call to action. Metabolism. 2020 Nov;112:154322. doi: 10.1016/j.metabol.2020.154322. Epub 2020 Jul 23. No abstract available.

  PMID: 32712223 BACKGROUND

• Wang R, DeGruttola V, Lei Q, Mayer KH, Redline S, Hazra A, Mora S, Willett WC, Ganmaa D, Manson JE. The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design. Contemp Clin Trials. 2021 Jan;100:106176. doi: 10.1016/j.cct.2020.106176. Epub 2020 Oct 10.

  PMID: 33045402 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Death

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• JoAnn E Manson, MD, DrPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Rui Wang, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Davaasambuu Ganmaa, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: December 28, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)