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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
Sponsor:
Collaborators:
University of Nottingham
Leeds Beckett University
Information provided by (Responsible Party):
Royal Centre for Defence Medicine

Brief Summary:

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:

  1. Any effect on symptomatic illness.
  2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
  3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time.
  4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method
  5. 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

Detailed Description:
The primary aim of this study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with reduced 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 study will be a Clinical Trial of an Investigational Medicinal Product (CTIMP) conducted by intention-to-treat over 24 weeks. It will follow a double-blind, randomized design comparing supplementation at a dose of 1000 I.U. vitamin D daily versus matched placebo in adults aged 18-30 years old. Participants will be recruited in Leeds to start in coincidence with the recommencement of Autumn semester. In accordance with our power calculation and anticipated drop-out rate, 2200 volunteers will be recruited to the intervention (vitamin D) arm, and 2200 to the placebo arm. Baseline serological testing of blood will be conducted to allow exclusion of prior seropositive individuals and any necessary upwards adjustment of recruited numbers. Data collected at baseline and 3-weekly during the remainder of the study will include seroconversion status assessed from a validated Dried Blood Spot (DBS) method in conjunction with novel salivary antibody testing, plus structured questionnaire responses screening for Covid-19 symptoms. Physical and demographic characteristics and serum levels of vitamin D concentrations collected from participants at study entry will facilitate secondary aims in relation to exploring the influence of gender, ethnicity, body mass and body mass index (BMI) on asymptomatic seroconversion, as well as interactions with vitamin D status and supplementation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.
Drug: Placebo
Placebo will be tested for size and appearance potency and contamination.
Other Name: Manufactured by Pure Encapsulations, Sudbury, MA, USA.




Primary Outcome Measures :
  1. Seroconversion [ Time Frame: 24 weeks ]
    asymptomatic seroconversion for SARS-CoV-2

  2. Interim analysis - seropositivity at 12 weeks [ Time Frame: 12 weeks ]
    asymptomatic seroconversion for SARS-CoV-2


Secondary Outcome Measures :
  1. Dried Blood Spot performance [ Time Frame: 24 weeks ]
    Sensitivity and specificity of dried blood spot assay compared with venous blood serology

  2. Salivary IgA performance [ Time Frame: 24 weeks ]
    Sensitivity and specificity of salivary IgA compared with venous blood serology

  3. 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.

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to access the study sites at Leeds Beckett University's Headingley or City campuses, UK.
  • In possession of an internet-enabled smart phone capable of receiving and responding to smartphone alerts.

Exclusion Criteria:

  • Previously diagnosed with COVID-19 either by RT-PCR or serologically (either prior to the study or at initial baseline testing).
  • Use of over-the-counter or prescribed vitamin D supplements currently or in the past month
  • Potential participants who are vegans will also be excluded since the study will use vitamin D3 derived from lanolin which, while acceptable to vegetarians is not acceptable to vegans.
  • Condition conferring 'very high risk' or 'high risk' of severe COVID-19

    • have had an organ transplant
    • are having chemotherapy or antibody treatment for cancer, including immunotherapy
    • are having an intense course of radiotherapy (radical radiotherapy) for lung cancer
    • are having targeted cancer treatments that can affect the immune system (such as protein kinase inhibitors or PARP inhibitors)
    • have blood or bone marrow cancer (such as leukaemia, lymphoma or myeloma)
    • have had a bone marrow or stem cell transplant in the past 6 months, or are still taking immunosuppressant medicine
    • are pregnant or intent on becoming pregnant during the anticipated study period
    • have a learning disability
    • have a lung condition (such as cystic fibrosis, asthma, COPD, emphysema or bronchitis)
    • have heart disease (such as heart failure)
    • have high blood pressure (hypertension)
    • have diabetes
    • have chronic kidney disease
    • have liver disease (such as hepatitis)
    • have a condition affecting the brain or nerves (such as Parkinson's disease, motor neurone disease, multiple sclerosis, or cerebral palsy)
    • have a problem with the spleen or have had the spleen removed
    • have a condition with high risk of getting infections (such as SCID, sickle cell, HIV, lupus or scleroderma)
    • are taking medicine that can affect the immune system (such as steroids)
    • are very obese (a BMI of 40 or above)

Information from the National Library of Medicine

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


Contacts
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Contact: David R Woods, MD 00441214158660 doctordrwoods@aol.com
Contact: John O'Hara, PhD 00441138125239 J.OHara@leedsbeckett.ac.uk

Locations
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United Kingdom
Headingley and City campuses, Leeds Beckett University
Leeds, Yorkshire, United Kingdom, LS6 3QQ
Contact: John O'Hara, PhD    00441138125239    J.OHara@leedsbeckett.ac.uk   
Sponsors and Collaborators
Royal Centre for Defence Medicine
University of Nottingham
Leeds Beckett University
Investigators
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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
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Responsible Party: Royal Centre for Defence Medicine
ClinicalTrials.gov Identifier: NCT04476680    
Other Study ID Numbers: 1062MODREC20
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised IPD may be available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Centre for Defence Medicine:
SARS-CoV-2
Cholecalciferol
Vitamin D Status
COVID-19
Acute Respiratory Tract Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Vitamin D Deficiency
Asymptomatic Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Respiratory Tract Diseases
Asymptomatic Diseases
Disease Attributes
Pathologic Processes
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents