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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 November 2020
Main ID:  EUCTR2019-000905-57-DK
Date of registration: 14/03/2019
Prospective Registration: Yes
Primary sponsor: The Department of Hepatology and Gastroenterology, Aarhus University Hospital
Public title: Efficacy of zinc on copper uptake in the body depending on zinc type and dose regimen measured with 64CuCl2 PET/CT-scan
Scientific title: Efficacy of zinc on human gut copper uptake depending on zinc type and dose regimen quantified with 64CuCl2 PET/CT-scan
Date of first enrolment: 17/04/2019
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-000905-57
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Denmark
Contacts
Name: Thomas Sandahl   
Address:  Palle Juul-Jensens Boulevard 99 8200 Aarhus N Denmark
Telephone:
Email: thomsand@rm.dk
Affiliation:  Aarhus University Hospital
Name: Thomas Sandahl   
Address:  Palle Juul-Jensens Boulevard 99 8200 Aarhus N Denmark
Telephone:
Email: thomsand@rm.dk
Affiliation:  Aarhus University Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age above 18
2. BMI < 25
3. Fertile women must accept to apply contraception at the time of the PET-scan: Spiral or hormonal contraception (contraceptive pill, implantation, transdermal patch, vaginal ring or depot injection)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Healthy volunteers (Wilson's disease)
MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Intervention(s)

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-

Trade Name: Zink "Natur-Drogeriet"
Pharmaceutical Form: Tablet
INN or Proposed INN: Zinc gluconate
CAS Number: 4468-02-4
Other descriptive name: ZINC GLUCONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: 64CuCl2
Pharmaceutical Form: Concentrate for oral solution
INN or Proposed INN: 64CuCl2
Other descriptive name: COPPER (64CU) CHLORIDE
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)
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.
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
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: The trial is expected to run from February 2019 to April 2020
Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
wilson12345
Source(s) of Monetary Support
Aarhus University Hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 28/03/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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