Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Vitamin D supplementation plus standard antidiabetic therapy: Uprise D3 60k IU once weekly for 12 weeks plus ongoing Glycomet GP2 and Jalra M 50/500 mg as per usual care follow up 24 we
Sponsors
Dr Kishor H
Eligibility
Inclusion criteria
Inclusion criteria: Adults 18 60 years with Type 2 Diabetes Mellitus Dyslipidemia HbA1C more than or equal to 7 percent Serum 25 hydroxyvitamin D less than or equal to 20 nanograms per millilitre, which is deficient or insufficient. On stable antidiabetic treatment with Glycomet GP2 and Jalra M 50/500 mg Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Type 1 diabetes Patients on insulin therapy High dose vitamin D use in past 1 month Hypercalcemia or current calcium supplements Severe renal impairment Hepatic dysfunction Steroid or anticonvulsant use affecting vitamin D metabolism Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycated hemoglobin (HbA1c) from baseline between intervention and control groups. Timepoint: Change in glycated hemoglobin (HbA1c) will be assessed after 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting blood glucose level from baseline.Timepoint: 0 week and 12 weeks.;Change in fasting lipid profile (total cholesterol, LDL, HDL, triglycerides).Timepoint: 0 week and 12 weeks.;Change in serum 25 hydroxyvitamin D level from baselineTimepoint: 0 week and 12 weeks;Incidence of adverse events related to vitamin D supplementationTimepoint: Throughout 24 week study period | — |
Countries
India
Contacts
Public ContactDr Anju Sarah Mathew
PES University Institute of Medical Sciences and Research
Outcome results
None listed