Zinc Supplementation and Inflammation in Older Medical Patients (ZOOM-IN)

ZOOM IN Study: Micronutrient Deficiencies and Effect of Zinc Supplementation on Inflammation and Occurrence of Infections in Older Medical Patients (ZOOM) - A Sub-study of a Cluster Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Older Medical Patients
• Intervention / Treatment: Dietary supplement: Zinc Supplement

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia M Lund, MD, PhD; Phone Number: +4538686112; Email: cecilia.margareta.lund.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients receiving zinc supplements (>10 mg daily) at time of inclusion
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controlgroup; Standard treatment
Active Comparator: Intervention; 22 mg zinc supplementation daily for 12 months	Dietary supplement: Zinc Supplement; 22 mg Zinc supplementation daily for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood samples indicating metabolic status and risk factors	Between group difference in change in triglycerids (mmol/L)	3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors	Between group difference in change in cholesterol (mmol/L)	3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors	Between group difference in change in HbA1c (mmol/mol)	3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors	Between group difference in change in albumin corrected zinc (μmol/L).	3 month, 6 month, 12 month
Patient reported Outcomes	Between group difference in change in Quality of life measured with EQ5D, and selfreported infections assessed with a homemaid, not validated questionnare.	3,6, and 12 months
Bodycomposition	between group difference in change in fat mass (kg) and muscle mass (kg) assessed with Bioimpedance analysis- BIA meassured at Baseline and after 3, 6 and 12 months	3, 6, and 12 months
Physical performance	between group difference in change in chair stand test 30second	3,6, and 12 month
Physical performance	between group difference in change in handgrip strength (kg)	3,6, and 12 month
Nutrition and zinc intake	estimating zinc intake using 24 hour recall assessment of nutritional intake. Assessing nutritional status with the Patient Generated Subjective Global Assessment (PG-SGA)	3,6, and 12 months
Inflammation changes at 12 months	Between group difference in change in IL6 (pg/ml), IL8 (pg/ml), YKL-40 (pg/ml) (IL6 at 6 months are primary outcomes)	3, 6, and 12 months
Methods for assessing zinc: Free zinc binding capacity(μmol/L) vs. plasma zinc(μmol/L) (with and without adjustments for albumin)	Evaluating the best way to assess zinc status in humans, and the association to occurring infections and readmissions	3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ZOOM-IN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No