Efficacy of zinc on copper uptake in the body depending on zinc type and dose regimen measured with 64CuCl2 PET/CT-scan

Efficacy of zinc on human gut copper uptake depending on zinc type and dose regimen quantified with 64CuCl2 PET/CT-scan

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000905-57-DK

Enrollment

Registered

2019-03-14

Start date

2019-04-17

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (Wilson's disease) MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850

Interventions

Trade Name: Wilzin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Zinc acetate CAS Number: 0005970-45-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age above 18 2. BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity for 64-Cu, copper in general or one of the other ingredients in the tracer formula 2. Claustrophobia 3. Pregnancy, breastfeeding or the desire to become pregnant before the trial is terminated.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of zinc on blocking human gut copper uptake in relation to the type of zinc (zinc acetate/zinc gluconate) and the dose regimen (once a day/ thrice a day). This is quantified by 64CuCl2 PET/CT scans. ;Secondary Objective: Not applicable ;Primary end point(s): 1. Zinc gluconate is not inferior to zinc acetate in blocking human gut copper uptake 2. 1 x 150 mg zinc acetate/gluconate daily is not inferior to 3 x 50 mg zinc acetate daily in blocking human gut copper uptake ;Timepoint(s) of evaluation of this end point: The trial is expected to run from February 2019 to April 2020	—

Measure

Time frame

Main Objective: To investigate the efficacy of zinc on blocking human gut copper uptake in relation to the type of zinc (zinc acetate/zinc gluconate) and the dose regimen (once a day/ thrice a day). This is quantified by 64CuCl2 PET/CT scans. ;Secondary Objective: Not applicable ;Primary end point(s): 1. Zinc gluconate is not inferior to zinc acetate in blocking human gut copper uptake 2. 1 x 150 mg zinc acetate/gluconate daily is not inferior to 3 x 50 mg zinc acetate daily in blocking human gut copper uptake ;Timepoint(s) of evaluation of this end point: The trial is expected to run from February 2019 to April 2020

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactThomas Sandahl

Aarhus University Hospital

thomsand@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026