diabetic macular edema. Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: The group receiving supplements included Vitamin D Pearls 50,000IU ( manufactured by Zahravi Company) and magnesium citrate sachets manufactured by Sajpad Darou Com
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Consent and willingness to to participate in the study Patient's age should be older than 18 years old Having type 2 diabetes Having diabetic macular edema: a central macular thickness(CMT, i.e., within the central 1 mm of the macula) of 270 microns or above, as determined by optical coherence tomography (OCT) imaging Best corrected visual acuity(BCVA) of 20/32 to 20/200 range in the affected eye according to Snellen Eye chart Over all eye status should be good for eye examination and optical coherence tomography (OCT) imaging(good pupil dilation,....)
Exclusion criteria
Exclusion criteria: History of other eye disease like cataract or Glaucoma ,... History of eye surgery Pregnancy or breastfeeding Taking magnesium or vitamin D supplements in the last three months Taking diuretics and laxatives containing magnesium Receiving antibiotics and bisphosphonates History of renal or hepatic disease History of uveitis Having other endocrine disease, such as thyroid dysfunction Diagnosis of any disease during the study period Any previous intravitreal injections (anti-VEGF agents, steroids, etc.), in last six month serum 25-hydroxyvitamin D level higher than 40ng/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin-6 serum levels. Timepoint: Before the start of the intervention and three months later. Method of measurement: Approved kit for measuring interleukin-6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnesium status. Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring Magnesium.;25-hydroxyvitamin D3. Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring 25-hydroxyvitamin D3.;Systolic blood pressure. Timepoint: Before the start of the intervention and three month later. Method of measurement: Mercury sphygmomanometer.;Fasting blood sugar. Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring Fasting blood sugar.;Diastolic blood pressure. Timepoint: Before the start of the intervention and three month later. Method of measurement: Mercury sphygmomanometer.;Low Density Lipoprotein (LDL). Timepoint: Before the start of the intervention and three month later. Method of measurement: Friedewald Equation for Low Density Lipoprotein.;Triglyceride (TG). Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring serum Triglyceride (TG).;High Density Lipoprotein(HDL). Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring serum High Density Lipoprotein(HDL).;Hemoglobin A1C(HbA1C). Timepoint: Before the start of the intervention and three month later. Method of measurement: Approved kit for measuring serum Hemoglobin A1C(HbA1C).;Central Macular Thickness (CMT). Timepoint: Before the start of the intervention and three month later. Method of measurement: Optical coherence tomography(OCT) imaging.;Best corrected visual acuity (BCVA). Timepoint: Before the start of the intervention and three month later. Method of measurement: by Snellen Eye Chart.;Weight. Timepoint: Before the start of the intervention and three month later. Method of measurement: measured by digital scale ( accuracy of scale:100 grams).;Body mass index(BMI). Timepoint: Before the sta | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Osfoori
Ahvaz University of Medical Sciences
Outcome results
None listed