A Randomized Double-Blind Placebo-Controlled Trial Evaluating the Efficacy of Oral Vitamin D3 in Improving Renal and Vascular Functions in Vitamin D Deficient Patients with Type 2 Diabetes Mellitus

Intramural fund0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•1.Patients of either gender aged between 18 and 65 years with type 2 diabetes mellitus with or without hypertension and has stable clinical profile and receiving treatment >= 3 months.
•2.Serum 25-hydroxy vitamin D level < 20 ng/ml.
•3.Estimated GFR (eGFR) between 30 and 60 mL/min/1.73m2.

•1.Patient on vitamin D-based therapy within 6 months prior to screening.
•2.Patients with symptomatic vitamin D deficiency
•3.Patient with a history of allergy or sensitivity to vitamin D or its analogues.
•4.Patient with blood pressure >= 160/100 mm Hg or < 80/60 mm Hg.
•5.Patient with uncontrolled diabetes: fasting blood glucose > 200 mg/dL or post prandial blood glucose > 350 mg/dL or HBA1C > 10.5%
•6.Patients with coexisting diseases, such as, chronic gastrointestinal disease, myocardial infarction, cerebrovascular accident, congestive heart failure, cardiomyopathies, peripheral vascular diseases, malignancies and renal stones.
•7.Patient with history of any drug or alcohol abuse <= 6 months prior to the screening.
•8.Patient has received any investigational drug <= 3 months prior to this study.
•9.Patient on any drugs modulating calcium metabolism and homeostasis.

发起方

Intramural fund