Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)
- Conditions
- Diabetic Nephropathies
- Interventions
- Dietary Supplement: Calcitriol
- Registration Number
- NCT02410005
- Lead Sponsor
- Weill Cornell Medical College in Qatar
- Brief Summary
This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.
- Detailed Description
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
- Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months
- Estimated eGFR of 30 to 90 mL/min/1.73 m2
- Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
- Serum Calcium > 2.45 mmol/L (9.8 mg/dL)
- Serum Phosphorus > 1.78 mmol/L (5.5 mg/dL)
- Serum Potassium > 5.5 mmol/L (5 mEq/L)
- Parathyroid hormone < 20 pg/mL or > 500 pg/mL
- Hemoglobin A1C > 12%
- 25-OH Vit D > 50 ng/mL
- Poorly controlled hypertension defined as systolic blood pressure >= 180 mm Hg or diastolic blood pressure >= 110 mm Hg
- History of kidney stones
- History of severe disease like chronic liver disease
- Active malignancy
- Active granulomatous diseases like turburculosis and sarcoidosis
- Recent diagnosis of acute renal failure within 3 months of screening visit
- Likelihood of renal replacement therapy within 1 year
- History of parathyroidectomy
- Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
- Currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. Subjects may also be taking stable dose of estrogen/progestin)
- History of osteoporosis or other bone disorder requiring calcitriol therapy
- History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
- History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
- Evidence of drug or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Losartan alone Losartan In the losartan alone group, subjects are prescribed: losartan 50mg twice daily. Losartan and Calcitriol Calcitriol In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily. Losartan and Calcitriol Losartan In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.
- Primary Outcome Measures
Name Time Method 24h urine 24hr urine albuminuria 12 month 24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Weill Cornell Medical College in Qatar
🇶🇦Doha, Qatar
Hamad Medical Corporation
🇶🇦Doha, Qatar
Weill Cornell Medical College
🇺🇸New York, New York, United States