Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at filtering urine. This is associated with albuminuria (protein in the urine). Treatment with some drugs reduces the loss of albumin through the urine and delays disease progression. There is increasing evidence that vitamin D could also be important in management of diabetic kidney disease. The aim of this study is to investigate the efficacy and safety of a combined regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in type 2 diabetes subjects with albuminuria. In the proposed study, the bioactive form of vitamin D (calcitriol) is being used for its ability to synergize with ACEI or ARB and prevent renal disease progression. The study expands on preliminary studies demonstrating a reduction in proteinuria with vitamin D analogue treatment, in subjects with both diabetic as well as non-diabetic kidney disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Active vitamin D (Calcitriol) 0.25 micrograms
Hamad Medical Corporation
Doha, Qatar
RECRUITINGUrinary albumin creatinine ratio (ACR) measured biochemically
Urine albumin and creatinine will be measured biochemically and their ratio calculated
Time frame: 26 weeks
24-hour urine albumin (24h UA) excretion
24-hour urine albumin (24h UA) excretion measured biochemically
Time frame: 26 weeks
Estimated glomerular filtration rate (eGFR)
Calculated using the Modification of Diet in Renal Disease (MDRD) equation
Time frame: 26 weeks
Blood pressure
Blood pressure measured using a digital sphygmomanometer
Time frame: 26 weeks
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