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Zinc and AMD.


- candidate number8676
- NTR NumberNTR2605
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2010
- Secondary IDsNL31655.091.10 CCMO
- Public TitleZinc and AMD.
- Scientific TitleSerum complement levels and the relation between zinc and Age-Related Macular Degeneration.
- ACRONYM
- hypothesisTo determine if zinc supplementation in AMD patients has a direct measurable effect on the complement system explaining the mechanism through which this substance exerts its influence on AMD progression.
- Healt Condition(s) or Problem(s) studiedAge-related macula degeneration, Zinc, Complement
- Inclusion criteria1. Men and women ≥ 50 years of age;
2. AMD patients previously included in the EUGENDA database;
3. Previously genotyped for Y402H (rs1061170) gene variation (from EUGENDA database);
4. Patients with extensive small drusen, intermediate drusen, large drusen, advanced neovascular AMD without neovascular activity in one or both eyes or geographic atropy in one or both eyes;
5. Informed consent.
- Exclusion criteria1. Active leakage from CNV due to AMD;
2. Ongoing anti/VEGF treatment;
3. Ongoing infection;
4. Subretinal hemorrhages;
5. History of any vitreous hemorrage within 12 weeks;
6. Other ocular disorders that may confound the interpretation of the study results;
7. Systemic or local steroid treatment within the last three months;
8. Use of any antibiotica;
9. Prolonged use of diuretics;
10. Supplemental use of iron (38-65 mg/day of elemental iron);
11. Use of zink and vitamin supplements one month prior to the study;
12. Systemic diseases that may influence complement levels (atypical haemolytic uraemic syndrome (aHUS), membranoproliferative glomerulonephritis type 2 (MG2)).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-jun-2010
- planned closingdate30-apr-2011
- Target number of participants80
- InterventionsAll participants of the study will receive oral 50 mg zinc as zinc sulfate and 1 mg copper as cupric sulphate dailly for 3 months.
- Primary outcomeThe primary outcome is the serum level of activation fragment C3d and complement component C3. The C3d/C3 ratio will be calculated. This ratio is the activity marker of the alternative complement pathway.
- Secondary outcomeThe secondary outcome is the correlation between this supposed drop in serum level C3 en C3d and Y402H polymorphism status in CFH.
- TimepointsSerum level of complement component C3 and activation fragments C3d will be analyzed prior, during and post treatment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Dzenita Smailhodzic
- CONTACT for SCIENTIFIC QUERIESDrs. Dzenita Smailhodzic
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryRationale:
Zinc and antioxidants supplementation can delay the progression of age-related macular degeneration (AMD). Compared to controls, AMD patients have a higher level of complement-mediated inflammation as demonstrated by subretinal complement deposits (drusen). The AREDS study has demonstrated that zinc supplementation may prevent the progression of AMD and preserve visual function in 21 % of patients. In addition, it has been demonstrated that zinc has the ability to temper activation of the complement cascade by direct binding to active complement molecules.

Objective:
1. To determine if zinc supplementation in AMD patients has a direct measurable effect on the complement system explaining the mechanism through which this substance exerts its influence on AMD progression;
2. To determine whether this proposed effect of zinc is influenced by the genetic status, regarding the Y402H and ARMS2 polymorphism, enabling us to identify subgroups of patients more susceptible to the beneficiary effect of zinc.

Study design:
80 AMD patients will be enrolled. These groups will receive 50 mg oral zinc supplements during 3 months. Serum level of complement component C3 and activation fragments C3d will be analyzed prior, during and post treatment.

Study population:
80 AMD patients of 50 years of age or older with extensive small, intermediate, and large drusen, geographic atrophy and/or exudative AMD but without active disease as demonstrated by active neovascularisation, will be recruited for the study.

Intervention:
All participants of the study will receive daily oral 50 mg zinc as zinc sulfate and 1 mg copper as cupric sulphate for 3 months. The reason for the presence of a small amount of copper is based on the fact that zinc and copper compete for the same membrane transport systems. The ratio zinc to copper in the present preparation reflects the physiological situation. The same reasoning has also been followed in the Age-Related Eye Disease Study (AREDS) of the National Institutes of Health in the US.
- Main changes (audit trail)
- RECORD17-nov-2010 - 1-dec-2010


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