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临床试验/IRCT20180922041089N1
IRCT20180922041089N1招募中2 期

The effect of vitamin D supplements in diabetic retinopathy in type 2 diabetic patients

Tehran University of Medical Sciences0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
35 years 至 no limit(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

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