NCT07672132

Brief Summary

The hypothesis is that a daily supplement of 22 mg of zinc over 12 months can reduce in-flammatory biomarkers in acutely hospitalized older adults aged ≥ 65 years. The aims are to determine, in acutely hospitalized older adults aged ≥ 65 years, if a daily supplement of 22 mg of zinc over 12 months compared to control can decrease inflammato-ry biomarkers, reduce symptoms of self-reported infection, reduce readmission and mortali-ty, increase QoL, increase physical performance, investigate potential adverse events to zinc supplement, and the changes in inflammatory biomarkers. It will also be studied if albumin-corrected zinc in plasma is a more accurate method for assessing zinc status than ordinary plasma zinc.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026May 2028

First Submitted

Initial submission to the registry

May 28, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

May 28, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • inflammation 6 months

    To evaluate the difference between the groups in plasma concentrations of IL-6 during the first 6-months. Endpoints: Plasma concentration of IL-6 (pg/ml) from baseline to 6 months

    6 months

Secondary Outcomes (11)

  • Blood samples indicating metabolic status and risk factors

    3 month, 6 month, 12 month

  • Blood samples indicating metabolic status and risk factors

    3 month, 6 month, 12 month

  • Blood samples indicating metabolic status and risk factors

    3 month, 6 month, 12 month

  • Blood samples indicating metabolic status and risk factors

    3 month, 6 month, 12 month

  • Patient reported Outcomes

    3,6, and 12 months

  • +6 more secondary outcomes

Study Arms (2)

Controlgroup

NO INTERVENTION

Standard treatment

Intervention

ACTIVE COMPARATOR

22 mg zinc supplementation daily for 12 months

Dietary Supplement: Zinc Supplement

Interventions

Zinc SupplementDIETARY_SUPPLEMENT

22 mg Zinc supplementation daily for 12 months

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • above 65 years old included in ZOOM out ( clinical trials no: NCT07367412)
  • admittet at the medical emergency department Herlev Hospital

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

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

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 26, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share