Diabetes mellitus
Conditions
Interventions
Those who become eligible will be assigned, randomly, using a computer generated random table, into two groups, therapy versus placebo. Test group will receive monthly dose of 50,000 IU of vitamin D3
Sponsors
University of Ruhuna
Eligibility
Inclusion criteria
Inclusion criteria: •HbA1c 30 mg/24 hours)
Exclusion criteria
Exclusion criteria: •Treatment with vitamin D or its analogues currently or during the last 12 months • Treatment with pharmacological doses of calcium • Serum total Ca > 10 mg/dl or 6mg/dl •Jaundice or confirmed liver disease lasting more than three months, currently or in the past • Decompensated congestive heart failure currently • Patients with hyperparathyroidism, hyperthyroidism or any disease leading to abnormalities in vitamin D or calcium metabolism • Fat malabsorption • Current UTI, renal TB or stones • Estimated GFR < 30ml / min/ 1.73m2(stage 4 and 5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of concomitant vitamin D3 therapy on albuminuria and renal functions in patients with early diabetic nephropathy [] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the prevalence of nephropathy among adult diabetics attending medical clinics in Teaching Hospital, Karapitiya (THK) and study their demographic and disease-related factors. 2) To determine, in a randomized clinical trial involving patients with early diabetic nephropathy, the effect of vitamin D therapy 2.1. on urinary albumin excretion. 2.2. on renal functions, as determined by serum creatinine and estimated GFR. 2.3. on cardiovascular morbidity and cardiovascular risk profile as determined by the Framingham cardiovascular risk score. 2.4. on plasma renin level. 2.5. on bone mineral density. (BMD) [] | — |
Countries
Sri Lanka
Contacts
Public ContactP L G C Liyanage
Probationary lecturer
Outcome results
None listed