Status:
COMPLETED
Vitamin D Supplementation in Diabetic Nephropathy
Lead Sponsor:
University of Alberta
Conditions:
Sub-optimal Vitamin D Status
Bone Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a ...
Detailed Description
Abstract: Vitamin D has a well-established role in bone health and the prevention of fractures which are associated with increased morbidity and mortality, and reduced quality of life. However, many ...
Eligibility Criteria
Inclusion
- Clinical diagnoses of diabetes (type 1 or 2) and stage 2-4 chronic kidney disease (glomerular filtration rate: 15-89 ml/min/1.73m2)
Exclusion
- Patients with co-morbid conditions known to affect vitamin D metabolism including gastrointestinal, liver, rheumatoid or bone disorders (e.g. hyperthyroidism, untreated celiac disease, cancer, Paget's disease, sarcoidosis, malabsorption, etc). Individuals with severe, permanent vision impairment will be excluded as this will preclude them from reading supplement labels accurately and safely. Pregnant women will be excluded as DXA scans are not recommended during pregnancy. Patients weighing \>136kg will be excluded as the DXA table cannot accommodate this weight.
- Patients on drug therapy known to interfere with vitamin D (e.g. oral glucocorticoids, cholestyramine, colestipol, mineral oil, Orlistat, digoxin, antacids).
- Patients with stage 5 CKD (GFR \<15ml/min/1.73m2), receiving dialysis or on kidney transplant list.
- Patients with pre-existing hypercalcemia (\>2.75mmol/l), hyperphosphatemia (\>2.0mmol/l), severe hyperparathyroidism (PTH \>600pg/ml), and serum 25(OH)D \>200nmol/l.
- Patients with serum 25(OH)D \<37.5nmol/l at time of study entry/screening to control for correction of vitamin D deficiency.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01476501
Start Date
October 1 2011
End Date
December 1 2015
Last Update
August 31 2022
Active Locations (1)
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1
Clinical Research Unit, University of Alberta
Edmonton, Alberta, Canada, T6G 0K2