a study to evaluate the role of vitamin-D supllementation in teatment of patints with type 2 diabetes
- Conditions
- Health Condition 1: null- Patients diagnosed of type 2 diabetes and who are vitamin-D defecient
- Registration Number
- CTRI/2012/10/003059
- Lead Sponsor
- Abbott Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Effect of Vitamin D supplementation on HbA1C, FPG and PPG in type 2 diabetic patientsTimepoint: Baseline, Day 30, Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method â?¢Efficacy of Vitamin D supplementation in raising 25 (OH) D levels in deficient type 2 diabetes patientsTimepoint: Baseline, Day 30 , Day 60 and Day 90