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Study the effect of vitamin D supplements on type 2 diabetes

Phase 2
Recruiting
Conditions
Diabetic retinopathy.
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy
E08.31
Registration Number
IRCT20180922041089N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

Age of at least 35 years
Patients with type 2 diabetes who are treated with insulin or combined therapy (insulin with antidiabetic pill)
They have NPDRP without the need for specific ophthalmologic treatment interventions
HbA1C levels below 8%
Systolic blood pressure up to 130
Diastolic blood pressure is up to 80 mmHg
Normal GFR is proportional to age based on MDRD formula
The amount of 24-hour urine albumin is less than 300 milligrams.

Exclusion Criteria

The history of any ocular disease (glaucoma, hypertensive retinopathy and cataract), or the history of eye surgery, or previous intra-ocular injections or visual acuity less than 6/10
History of chronic disease such as sarcoidosis, hyperparathyroidism and seizure, bone cancer or lung and liver cirrhosis and...
History of bariatric surgery or absorption disorders or any other disease indicating vitamin D intake.
History of kidney stones
Pregnancy and lactation
History of taking phenofibrate, thiazolidinedione, anticonvulsants, or drugs that interfere with the metabolism of vitamin D or produce eye effects, including macular edema.
The history of severe psychiatric illnesses such as schizophrenia, mood disorders, borderline disorders.
Regular supplementation of D supplementation in the last three months or during the study (in the control group)
History of any drug allergy or side effects.
Participants are reluctant to take drugs or placebo
Participate in another research project over the past 3 months
HbA1C levels of 8% and more
Glucocorticoid intake in the last 3 months
BMI more than 35
The amount of 24-hour urine albumin exceeds 300 milligrams
The GFR is greater than the normal range based on the age-appropriate MDRD formula.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Diabetic retinopathy. Timepoint: Start studying, 3months later, 6months later. Method of measurement: ETDRS scale.
Secondary Outcome Measures
NameTimeMethod
Body mass index. Timepoint: Start studying, 6 months later. Method of measurement: measurement.;HA1C test. Timepoint: Start studying, 6 months later. Method of measurement: Laboratory measurement.;Macular thickness. Timepoint: Start studying, 6 months later. Method of measurement: OCT.
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