Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease (RAID-CoV-2)
|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: NCT04476680|
Recruitment Status : Not yet recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults.
The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo.
The secondary aims of this study are to explore:
- Any effect on symptomatic illness.
- The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
- The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time.
- Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method
- The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV Infection Vitamin D Deficiency Covid19 Acute Respiratory Tract Infection||Dietary Supplement: Vitamin D 1000 IU Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind randomized design comparing 1000 I.U. vitamin D versus matched placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Allocation by computer-generated randomisation schedule (http://www.randomization.com) The vitamin D supplement and the placebo supplement will be manufactured by Pure Encapsulations, Sudbury, Massachusetts, USA. To ensure double-blinding for the investigator and participant in situ, the active and placebo supplements will be presented as identical (size and appearance) tablets that will be indiscernible from each other.|
|Official Title:||Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||April 28, 2021|
|Estimated Study Completion Date :||April 28, 2021|
Experimental: 1000 I.U. Vitamin D supplement per day
The 1000 I.U. vitamin D supplement will be manufactured by Pure Encapsulations, Sudbury, Massachusetts, USA.
Dietary Supplement: Vitamin D 1000 IU
Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.
Other Name: Pure Encapsulations, Sudbury, MA, USA
Placebo Comparator: Placebo
The placebo will be manufactured by the same manufacturer as the interventional supplement and will be identical in size and appearance.
Placebo will be tested for size and appearance potency and contamination.
Other Name: Manufactured by Pure Encapsulations, Sudbury, MA, USA.
- Seroconversion [ Time Frame: 24 weeks ]asymptomatic seroconversion for SARS-CoV-2
- Interim analysis - seropositivity at 12 weeks [ Time Frame: 12 weeks ]asymptomatic seroconversion for SARS-CoV-2
- Dried Blood Spot performance [ Time Frame: 24 weeks ]Sensitivity and specificity of dried blood spot assay compared with venous blood serology
- Salivary IgA performance [ Time Frame: 24 weeks ]Sensitivity and specificity of salivary IgA compared with venous blood serology
- Prevalence of SARS-CoV-2 [ Time Frame: 24 weeks ]The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
- Change in seropositivity [ Time Frame: 24 weeks ]The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time
- Change in seroconversion rate [ Time Frame: 24 weeks ]The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity
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): NCT04476680
|Contact: David R Woods, MDfirstname.lastname@example.org|
|Contact: John O'Hara, PhD||00441138125239||J.OHara@leedsbeckett.ac.uk|
|Headingley and City campuses, Leeds Beckett University|
|Leeds, Yorkshire, United Kingdom, LS6 3QQ|
|Contact: John O'Hara, PhD 00441138125239 J.OHara@leedsbeckett.ac.uk|
|Study Chair:||David R Woods, MD||Royal Centre of Defence Medicine, Birmingham, UK|
|Principal Investigator:||Jonathan S Nguyen-Van-Tam, MD||University of Nottingham, UK|
|Principal Investigator:||Julie P Greeves, PhD||Army Health and Performance Research, Andover, UK|