NCT03216564

An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes

Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	Calcitriol	Active vitamin D (Calcitriol) 0.25 micrograms

Timeline

• Start date: 2017-05-10
• Primary completion: 2019-05-10
• Completion: 2019-05-10
• First posted: 2017-07-13
• Last updated: 2018-09-06

Locations

1 site across 1 country: Qatar