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
About this trial
This is an interventional prevention trial for Respiratory Tract Infections
Eligibility 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.
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
NCT ID
NCT04596657
First Posted
October 15, 2020
Last Updated
July 21, 2023
Sponsor
The Cooper Health System
Collaborators
Won Sook Chung Foundation
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
Learn more about this trial
Vitamin D3 Supplementation to Prevent Respiratory Tract Infections
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