Zinc Supplementation and Infections in Older Medical Patients

NCT07367412 | Not Yet Recruiting DMC

• 1 other identifier: ZOOM OUT
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adults (65 Years and Older); Medical Patients in the Emergency Department

Keywords

Older adults; Infections; Days alive and out of hospital; Zinc supplementation

Outcome Measures

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

  During the 12 months follow-up period

Secondary Outcomes (5)

• Antibiotic use

  During the 12 months follow-up period

• Hospital admissions

  During the 12 months follow-up period

• Readmission due to cardiovascular disease

  During the 12 months follow-up period

• Readmissions due to infections

  During the 12 months follow-up period

• Mortality

  During the 12 months follow-up period

Study Arms (3)

Intervention

ACTIVE COMPARATOR

The intervention group will consist of 1000 patients who following discharge from the hospital will have daily zinc supplements prescribed and provided free of charge which will be sent to their home for a year.

Dietary Supplement: Zinc (zinc sulphate)

Recommendation group

EXPERIMENTAL

The recommendation group will consist of 3000 patients who will have zinc supplements recommended and prescribed. However, zinc supplements will not be provided free of charge.

Dietary Supplement: Zinc (zinc sulphate)

Control group

NO INTERVENTION

The control group will consist of 4000 patients who will receive usual care

Interventions

Zinc (zinc sulphate) DIETARY_SUPPLEMENT

22 mg zinc sulphate tablets taken once daily for 12 months

Intervention; Recommendation group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Patients know with known severe dementia
• Patients who do not understand Danish and patients with temporary civil person registration numbers (CPR)

Sponsors & Collaborators

• The Novo Nordic Foundation: collaborator
• Herlev Hospital: lead
• Independent Research Fund Denmark: collaborator

Study Sites (1)

Department of Medicine, Copenhagen University Hospital - Herlev and Gentofte

Herlev, 2730, Denmark

Location

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MeSH Terms

Conditions

Infections

Interventions

Zinc; Zinc Sulfate

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Central Study Contacts

Cecilia M Lund, Senior consultant, PhD

CONTACT

+45 38686112; cecilia.margareta.lund@regionh.dk

Pernille H Ellegaard, MD, PhD student

CONTACT

+45 38681616; pernille.holm.ellegaard.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a cluster randomized controlled trial. Patients ≥ 65 years referred to the Medical Emergency Department at Herlev Hospital, and meet the inclusion criteria, will be randomized to participate in the study. Randomization In EPIC (Sundhedsplatformen) a generic module has been developed that facilitate cluster-level randomization directly in the system. In this study, clusters of time, will be used to randomly assign groups of patients to intervention with zinc supplementation (intervention n = 1000), recommendation of zinc supplementation (recommendation n = 3000), or usual care (control n = 4000). An automatic pop-up in EPIC (Sundhedsplatformen) will occur when a doctor opens the patients electronic medical chart. The randomization will occur based on unequal time windows with the same ratio of hours (8:6:2 hours) to ensure the anticipated segregation of 4:3:1. The time windows will be shifting an agreed number of minutes every day.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be avilable from January 2029 to 2034 and
• Access Criteria: Will be available from the corresponding author upon reasonable request and only after approval has been granted by an ethics committee.

Locations

DK (1)