Research Center: Harvard Medical School – Brigham and Women’s Hospital
Location: This is a nationwide study conducted remotely (no travel or study visits)
Lead Researchers: JoAnn Manson, MD, Dr.P.H.; Rui Wang, Ph.D.
IRB Committee: This study has been reviewed and approved by the Mass General Brigham Ethics Board

Background

According to the World Health Organization (WHO), as of February 9, 2021, there have been more than 100 million confirmed cases of COVID-19 worldwide. Many teams of researchers across the world are looking into ways to help protect communities from COVID-19 and its related symptoms.

A supplement is a product, often in the form of a pill, that provides vitamins, minerals, or other essential nutrients required for a healthy diet. Vitamin D is a dietary supplement. However, it is unknown if vitamin D can prevent or treat COVID-19. This research study seeks to learn if taking high doses of vitamin D daily reduces the risk of severe symptoms among adults newly diagnosed with COVID-19 (a positive test for COVID within the past 7 days). Researchers also want to determine if daily vitamin D reduces the risk of infection for people who are household members of someone diagnosed with COVID in the past 7 days.

This nationwide research study is inviting adults aged 18 years old or older who have been newly diagnosed with COVID-19 (positive test in the past 7 days). It is also enrolling people who live in the same household as someone who received a positive test for COVID in the past 7 days. Participants must be willing to comply with the necessary study requirements. Compensation in the form of gift cards will be provided to eligible individuals for completing the activities required for the study participation. 

Why Participate? 

• You will receive the study vitamin D or vitamin D placebo pills at no cost. The study team will mail you your study pills in a 4-week supply. 
• You may be able to prevent complications that may arise due to COVID-19.
• You may help develop a natural preventive care option to fight COVID-19.
• You will contribute valuable information that may benefit the community during this pandemic.
• You will be compensated up to $20 in gift cards for providing 2 finger prick blood samples for this study.
• You will be helping to advance medical and COVID-related research.
• Qualified health professionals are conducting this research study.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.

Who Can Participate?

• Adults aged 18 years old or older who have been newly diagnosed with COVID-19 within the last 7 days. 
• Adults aged 18 years old or older who live in the same household as someone who received a positive test for COVID in the past 7 days.
• Participants must not be currently hospitalized. 
• Participants must be willing to commit to this approximately 8-week research study. Participants will be asked to: 
  • Complete study questionnaires. 1 at the beginning of the study, weekly for 4 weeks, and 1 follow-up questionnaire after the study has ended. The questionnaires, which take about 15-20 minutes to complete, will contain questions about the participant’s health and use of medications and dietary supplements.
  • Take the study pills as instructed by the study team. 
  • Provide 2 blood spot samples. The dried blood spot sample collection kit will be mailed to your home. Your blood sample will be collected through a finger prick onto a filter paper. The blood sample will be stored and used for testing of Vitamin D levels. Your blood sample will also be tested for COVID-19 antibodies.

• If needed, the study team may give the participant a phone call to get new information or to clarify answers that the participant may have. The study may also email or text the participant reminders to take their study pills, complete their finger prick blood spot sample, and complete the study questionnaires. 

About the Research Center:

Harvard Medical School

Established in 1782, Harvard Medical School is currently the top-ranked medical school in the U.S. and has been expanding the boundaries of medical knowledge for more than 200 years.