]>
IRCT20180922041089N1 IRCT 2019-01-24 Tehran University of Medical Sciences Study the effect of vitamin D supplements on type 2 diabetes DRD The effect of vitamin D supplements in diabetic retinopathy in type 2 diabetic patients 2018-12-22 anticipated 100 Complete https://irct.ir/trial/36495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Regarding the high prevalence of diabetes and the consequent increase in the prevalence of diabetic retinopathy in Iran and the growing health problem due to reduced visual acuity and blindness of the population with diabetic retinopathy, which is often active in working age, and preventable blindness due to Referring to the fact that family physicians are the first level of exposure to diabetic patients, if there is a positive result in this study, it is recommended that vitamin D supplements be used in all diabetic patients to prevent the development of diabetic retinopathy, Randomization description: The random allocation role method will be used. There are 30 green cards (interventions) and 30 orange cards (controls) inside white envelopes for women and the same number for men that were placed inside two separate lottery boxes and randomly each eligible patient will be assigned a card according to the sex, Blinding description: In order to eliminate the bias caused by the patient's or doctor's knowledge of the received treatment type and its possible effect on the outcome of the study, the study is done in two blind ways. Considering that the vitamin D and placebo tablets are placed in the same capsule, the patient and the assessing physician are not aware of the type of received drug. 2 Diabetic retinopathy. Intervention 1: Intervention group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. During a visit, after 3 months of onset of the study, photogramography Digital Retinol is used to diagnose diabetic syringropathy. Patients in the target group treated with vitamin D were checked for vitamin D monitoring during the third month of their visit. Patients re-enter the specialty internists and ophthalmologists after 6 months of admission. The level of HbA1c marker hyalipid is checked and checked by an ophthalmologist and ophthalmologist, fluorosine angiography and OCT, and digital retinal photogramography for patients Done. Intervention 2: Control group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. The on-site, placebo-controlled, Once receive. All patients are followed up at the beginning of the study 3 months later and 6 months later by an intern doctor and an ophthalmologist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is a publishing program for study, but there is currently no decision to publish.
public Abolfazl Zendehdel
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences scientific Abolfazl Zendehdel
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 35 years no limit Both 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. E08.31 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy Treatment - Drugs Treatment - Drugs Intervention group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. During a visit, after 3 months of onset of the study, photogramography Digital Retinol is used to diagnose diabetic syringropathy. Patients in the target group treated with vitamin D were checked for vitamin D monitoring during the third month of their visit. Patients re-enter the specialty internists and ophthalmologists after 6 months of admission. The level of HbA1c marker hyalipid is checked and checked by an ophthalmologist and ophthalmologist, fluorosine angiography and OCT, and digital retinal photogramography for patients Done. Control group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. The on-site, placebo-controlled, Once receive. All patients are followed up at the beginning of the study 3 months later and 6 months later by an intern doctor and an ophthalmologist. Diabetic retinopathy. Timepoint: Start studying, 3months later, 6months later. Method of measurement: ETDRS scale. 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. Grant Proposals Approved 2018-07-21 National Ethics Committee for Biomedical Research Abuzar St, Ziaian Hospital, Tehran Town Tehran Tehran Iran (Islamic Republic of)