Zinc Supplementation and Infections in Older Medical Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHerlev Hospital

About this trial

The goal of this clinical trial is to learn about the effect of zinc supplementation once daily for 12 months in older acute medical patients. The main question it aims to answer is:

• Can daily zinc supplementation for 12 months increase Days Alive and Out of Hospital (DAOH)? Researchers will compare zinc supplementation to a control group, a group who do not receive zinc supplementation, to see if zinc supplementation can increase Days Alive and Out of Hospital, reduce antibiotic use, readmissions and mortality.

Participants will take 22 mg zinc supplementation once daily for 12 months or not.

The researchers will draw data on readmissions, antibiotic use and mortality during the 12 months follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All medical patients aged ≥ 65 years assessed at the Medical Emergency Department, Herlev Hospital

Disqualifiers

Self-supplementing with zinc at time of assessment (> 10 mg zinc/day)

Terminal illness (life expectancy < 6 months, estimated by Clinical Frailty Scale ≥8)

Patients receiving parenteral nutrition (partial or complete)

Patients treated with hemodialysis or peritoneal dialysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc (zinc sulphate)

    Dietary supplement

    22 mg zinc sulphate tablets taken once daily for 12 months

Treatment groups

8,000 Participants
are divided into 3 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: Recommendation groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Days Alive and Out of Hospital

To evaluate the differences between the groups in Days Alive and Out of Hospital. The endpoints will include date of death, date of hospitalization, and number of days hospitalized during the 12 months follow-up period in the three groups

Time frame
During the 12 months follow-up period

Secondary outcomes

1

Antibiotic use

Number of episodes with use of antibiotic

Time frame
During the 12 months follow-up period
2

Hospital admissions

Number of hospital episodes of any cause

Time frame
During the 12 months follow-up period
3

Readmission due to cardiovascular disease

Number of readmissions due to cardiovascular disease

Time frame
During the 12 months follow-up period
4

Readmissions due to infections

Number of readmissions due to infections

Time frame
During the 12 months follow-up period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Herlev Hospital

Lead sponsor

Independent Research Fund Denmark

Collaborator

The Novo Nordic Foundation

Collaborator