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Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

Primary Purpose

Respiratory Tract Infections, Covid19, Flu Like Illness

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D supplementation
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cooper University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Influenza-like illness
Incidence of influenza-like illness

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
July 21, 2023
Sponsor
The Cooper Health System
Collaborators
Won Sook Chung Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04596657
Brief Title
Vitamin D3 Supplementation to Prevent Respiratory Tract Infections
Official Title
Vitamin D3 Supplementation to Prevent Respiratory Tract Infections, Including Covid-19, in Hospital Workers: a Pragmatic Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
Collaborators
Won Sook Chung Foundation

4. Oversight

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

5. Study Description

Brief Summary
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.
Detailed Description
Influenza-like illness and covid-19 were added to this summary because the protocol uses respiratory tract infections and influenza-like illness interchangeably. Influenza-like illness is more accurate. Protocol amendments: Protocol title was amended to include covid-19. Minimum age was changed from 52 to 18, expanding the sample size. Exclusion criteria re vitamin D intake was changed from >5000 to >=5000 IU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Covid19, Flu Like Illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
877 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplementation
Intervention Description
Daily vitamin D3 supplementation (5000 IU)
Primary Outcome Measure Information:
Title
Influenza-like illness
Description
Incidence of influenza-like illness
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hospital worker Age 18 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 Employee is team member on the present study If potential participants are found to be using vitamin D supplementation upon screening at a daily dose ≤5000 IU/day, they will be eligible for participation by switching to the study dose. If potential participants are taking a multiple vitamin or calcium supplement and there is less than or equal to 800 IU vitamin D in it, they can continue the multivitamin or calcium supplement along with taking the study vitamin D3. Total vitamin D cannot exceed 5,800 IU per day combined between any supplements that contain vitamin D. Use of vitamin D at a daily dose > 5000 IU at the direction of a physician will be an exclusion criterion. If a potential subject uses over-the-counter vitamin D not directed by a physician at a daily dose > 5000 IU they will be eligible to participate by switching to the lower study dose.
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

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