Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

• Sponsor: The Cooper Health System (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04596657
• Collaborator: The Won Sook Chung Foundation (Other)
• Enrollment: 876
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 37.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 876 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: Oct 27, 2020
• Actual Primary Completion Date: Nov 30, 2021
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Respiratory tract infection [9 months]

   Incidence of acute respiratory tract infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 52 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cooper University Hospital	Camden	New Jersey	United States	08103

Sponsors and Collaborators

• The Cooper Health System
• The Won Sook Chung Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cooper Health System
• ClinicalTrials.gov Identifier: NCT04596657
• Other Study ID Numbers: 20-455
• First Posted: Oct 22, 2020
• Last Update Posted: Jan 6, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Infections; Communicable Diseases; Respiratory Tract Infections; Vitamin D

Study Results

No Results Posted as of Jan 6, 2022