A Randomized, two arm, single centre study to assess the effect of Vitamin D supplementation on glycemic control in type 2 diabetes patients who are not well controlled on current treatment and who are vitamin D deficient.

Abbott Healthcare Pvt Ltd0 个研究点目标入组 110 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Men and women >18 years of age, upper limit at the discretion of Investigator
•2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus at least 6 months prior to screening
•3.Patients with HBA1c >7.5% and <10 % who are stable on dual drug therapy (Sulfonylurea + Metformin ) for last 2 months and having 25(OH)D levels are <20ng/dl during screening visit.
•4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed

•1.Type-1 diabetes mellitus
•2.Pregnant & lactating patients
•3.Patients who have hypersensitivity to vitamin D granules.
•4.Patients with renal calculi.
•5.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
•6.Cardiac status New York Heart Association (NYHA) III-IV
•7.Impaired renal function as shown by, but not limited to, serum creatinine >= 1.5 mg/dL for males, or >= 1.4 mg/dL for females
•8.Subject with anticipated need of surgery within study period.
•9.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
•10.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
•11.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
•12.Any other condition according to investigator

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