Diabetic Retinopathy. Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: Vitamin D supplement with a dose of 50,000 units weekly (D-Vigel 50,000 IU, Daana Pharmaceutical company, Iran). Intervention 2: Control group: receive placebo medi
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes and diabetic macular edema Age 18 and above The central thickness of the macula is higher than 300 µm Serum Vitamin D level less than 30 ng/ml
Exclusion criteria
Exclusion criteria: History of any eye surgery other than uncomplicated cataract surgery at least six months ago History of intravitreal injection of bevacizumab and other anti-VEGF (vascular endothelial growth factor) drugs and steroids during the last three months. History of retinal vascular events History of macular traction , the presence of macular disease due to a cause other than diabetes History of thyroiditis in women, pregnant and lactating women Taking vitamin D supplements at the time of entering the study Severe vitamin D deficiency less than 10 ng/ml Hypercalcemia Hyperphosphatemia Serum creatinine is more than 3 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central macular thickness. Timepoint: Before the intervention, one month, 2 months and 3 months after the intervention. Method of measurement: Central thickness of the macula measurement with Optical Coherence Tomography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Distance corrected visual aquity. Timepoint: Before the intervention, one month, 2 months, 3 months after the intervention. Method of measurement: Visual acuity E chart. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArash Daneshtalab
Kerman University of Medical Sciences
Outcome results
None listed