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Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

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ClinicalTrials.gov Identifier: NCT04596657
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
The Won Sook Chung Foundation
Information provided by (Responsible Party):
The Cooper Health System

Study Description
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Brief Summary:
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections in hospital workers.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Covid19 Flu Like Illness Dietary Supplement: Vitamin D supplementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vitamin D3 Supplementation to Prevent Respiratory Tract Infections in Hospital Workers: a Pragmatic Study
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Dietary Supplement: Vitamin D supplementation
Daily vitamin D3 supplementation (5000 IU)
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Respiratory tract infection [ Time Frame: 9 months ]
    Incidence of acute respiratory tract infection


Eligibility Criteria
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Ages Eligible for Study:   52 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hospital worker
  • Age 52 years or older

Exclusion Criteria:

  • History of hypercalcemia
  • History of nephrolithiasis
  • History of intolerance to vitamin D3 supplements
  • Use of calcium at a dose > 600 mg/day (individuals using a dose greater than 600 mg of calcium per day will be asked to limit the amount to 600 mg unless they have been directed by their physician to be taking more than 600 mg/day of calcium. If the latter is true the potential subject will be excluded from the study.)
  • Use of vitamin D at a daily dose ≥ 5000 IU*
  • Use of aluminum-containing phosphate binders in patients with renal failure
  • Use of calcipotriene
  • Use of digoxin

  • Use of thiazide diuretics if using:

    • hydrochlorothiazide at a daily dose > 37.5 mg
    • indapamide at a daily dose > 1.25 mg
    • chlorthalidone at a daily dose > 12.5 mg
    • metolazone at a daily dose > 2.5 mg
    • methyclothiazide at a daily dose > 2.5 mg
    • chlorothiazide at a daily dose > 250 mg
    • metolazone at a daily dose > 0.5 mg
    • bendroflumethiazide at a daily dose > 2.5 mg
    • polythiazide at a daily dose > 1 mg
    • hydroflumethiazide at a daily dose > 25 mg
  • Conditions that are associated with a risk of modified vitamin D metabolism
  • Known allergy to wool
  • Current enrollment in another study
  • Life expectancy <1 month at time of screening
  • Cognitive impairment precluding the ability to provide informed consent

  • Pregnant or trying to become pregnant

    • If potential participants are found to be using vitamin D supplementation upon screening at a daily dose lower than 5000 IU/day, they will be eligible for participation by switching to the higher study dose. If potential participants are taking a multiple vitamin and there is less than or equal to 800 IU vitamin D in it, they can continue the multivitamin along with taking the study vitamin D3. If potential participants are found to be using vitamin D supplementation at a daily dose greater than or equal to 5000 IU they will not be eligible to participate in the study.
Contacts and Locations
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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): NCT04596657


Contacts
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Contact: Noud van Helmond, MD (800) 826-6737 vanhelmond-noud@cooperhealth.edu

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Noud van Helmond, MD         
Sponsors and Collaborators
The Cooper Health System
The Won Sook Chung Foundation
More Information
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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT04596657    
Other Study ID Numbers: 20-455
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Vitamins
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents