Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

Vitamin D3 Supplementation to Prevent Respiratory Tract Infections, Including Covid-19, in Hospital Workers: a Pragmatic Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Covid19; Flu Like Illness
• Intervention / Treatment: Dietary supplement: Vitamin D supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 877
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Dietary supplement: Vitamin D supplementation; Daily vitamin D3 supplementation (5000 IU)
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza-like illness	Incidence of influenza-like illness	9 months

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Collaborators: Won Sook Chung Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 20-455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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