Effect of vitamin D3 on progression of diabetic nephropathy

Not Applicable

Recruiting

Conditions: Diabetes mellitus

Registration Number: SLCTR/2009/008

Lead Sponsor: niversity of Ruhuna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•HbA1c < 8% •Blood pressure = or <130/80 mm Hg •Confirmed microalbuminuria or macroalbuminuria( >30 mg/24 hours)

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 <8.4 •Serum phosphate > 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of concomitant vitamin D3 therapy on albuminuria and renal functions in patients with early diabetic nephropathy<br> []<br>

Secondary Outcome Measures

Name	Time	Method
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)<br> []<br>