Status:
COMPLETED
Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects
Lead Sponsor:
Atlanta VA Medical Center
Conditions:
Chronic Kidney Disease
Vitamin D Deficiency
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be ...
Detailed Description
Vitamin D supplementation in reducing secondary hyperparathyroidism in chronic kidney disease patients, stage 3 and 4: A randomized, placebo controlled pilot study Problem of interest Chronic Kidney D...
Eligibility Criteria
Inclusion
- Age 18-85
- CKD stage 3-4 (GFR 15-59 ml/min/1.73 m2 body surface area, calculated by using the MDRD Study equation GFR Calculator)
- serum 25(OH)D concentrations ≤ 30 ng/mL, and serum PTH levels \>70 pg/mL documented within the last six months
Exclusion
- History of liver failure (serum AST or ALT \> 3-fold the upper limit of normal)
- requiring dialysis at any stage of the study
- history of intestinal malabsorption or chronic diarrhea
- serum calcium level (corrected for serum albumin) \> 10.5 mg/dL
- calcium x phosphorus product \>70
- treatment with more than 1000 IU of vitamin D per day, or current treatment with a vitamin D analogue or calcimimetic
- an anti-epileptic medication and other medications which can affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00427037
Start Date
December 1 2005
End Date
March 1 2013
Last Update
July 22 2015
Active Locations (1)
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1
Emory Clinic
Atlanta, Georgia, United States, 30322