NCT04596657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
877

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 15, 2020

Last Update Submit

December 6, 2023

Conditions

Respiratory Tract InfectionsCovid19Flu Like Illness

Outcome Measures

Primary Outcomes (1)

  • Influenza-like illness

    Incidence of influenza-like illness

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL
Dietary Supplement: Vitamin D supplementation

Control

NO INTERVENTION

Interventions

Vitamin D supplementationDIETARY_SUPPLEMENT

Daily vitamin D3 supplementation (5000 IU)

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital worker
  • Age 18 years or older

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCOVID-19

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPneumonia, ViralPneumoniaVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

October 27, 2020

Primary Completion

November 23, 2021

Study Completion

October 19, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

US(1)