NCT02410005

Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)

Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Weill Cornell Medical College in Qatar · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Nephropathies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcitriol
DRUG	Losartan

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-07
• Completion: 2015-09-07
• First posted: 2015-04-07
• Last updated: 2017-06-15

Locations

3 sites across 2 countries: United States, Qatar