Vitamin D3 Supplementation to Prevent Respiratory Tract Infections
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04596657 |
Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Tract Infections Covid19 Flu Like Illness | Dietary Supplement: Vitamin D supplementation | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention |
Dietary Supplement: Vitamin D supplementation
Daily vitamin D3 supplementation (5000 IU) |
No Intervention: Control |
- Respiratory tract infection [ Time Frame: 9 months ]Incidence of acute respiratory tract infection

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Ages Eligible for Study: | 52 Years and older (Adult, Older Adult) |
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
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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.

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
Contact: Noud van Helmond, MD | (800) 826-6737 | vanhelmond-noud@cooperhealth.edu |
United States, New Jersey | |
Cooper University Hospital | Recruiting |
Camden, New Jersey, United States, 08103 | |
Contact: Noud van Helmond, MD |
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 |
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 |
Infection Communicable Diseases Respiratory Tract Infections Respiratory Tract Diseases Vitamin D Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |