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Serum complement levels and the relation between zinc and Age-Related Macular Degeneration.

Serum complement levels and the relation between zinc and Age-Related Macular Degeneration. - Zink supplementation in AMD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35087
Enrollment
51
Registered
2010-04-20
Start date
2010-06-04
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

AMD Macular Degeneration

Interventions

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.

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Men and women >= 50 years of age. • AMD patients previously included in the EUGENDA database. • Previously genotyped for Y402H (rs1061170) gene variation (from EUGENDA database). • 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. • Informed consent.

Exclusion criteria

Exclusion criteria: • Active leakage from CNV due to AMD. • Ongoing anti/VEGF treatment. • Ongoing infection. • Subretinal hemorrhages. • History of any vitreous hemorrage within 12 weeks. • Other ocular disorders that may confound the interpretation of the study results. • Systemic or local steroid treatment within the last three months. • Use of any antibiotica. • Prolonged use of diuretics. • Supplemental use of iron (38-65 mg/day of elemental iron). • Use of zink and vitamin supplements one month prior to the study. • Systhemic diseases that may influence complement levels (atypical haemolytic uraemic syndrome (aHUS), membranoproliferative glomerulonephritis type 2 (MG2)).

Design outcomes

Primary

MeasureTime frame
The primary outcome is the serum level of activation fragment C3d and complement component C3, C3d/C3 ratio will be calculated. This ratio is the activity marker of alternative complement pathway.

Secondary

MeasureTime frame
The secondary outcome is the correlation between this supposed drop in serum level C3d and Y402H polymorphism status in CFH.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)