Vitamin D Supplementation in Kidney Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Renal Dialysis
- Vitamin D Deficiency
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 89 years
- Gender
- Both males and females
Description
Patients will first be identified based on the inclusion criteria, then informed about the study and consented. Those who meet the exclusion criteria will be randomized to treatment or placebo. Enrolled participants will be randomized 2:1 to receive vitamin D (n=20) or placebo (n=10) for 6 months. A...
Patients will first be identified based on the inclusion criteria, then informed about the study and consented. Those who meet the exclusion criteria will be randomized to treatment or placebo. Enrolled participants will be randomized 2:1 to receive vitamin D (n=20) or placebo (n=10) for 6 months. All participants will be tested twice over two weeks to establish baseline values. Following baseline testing, the treatment group will receive 50,000 IU (standard replacement therapy) of oral cholecalciferol or placebo. The initial dose of cholecalciferol will be 50,000 IU weekly for 6 weeks. Vitamin D levels will then be measured. Participants who still have Vitamin D insufficiency ( 35 ng/ml) will remain on 50,000 IU of cholecalciferol for another 6 weeks, at which point Vitamin D levels will be measured again. Participants who reach 25-OH levels > 35 ng/ml will have their dosing regimen lessened to 10,000 IU weekly (maintenance dose) for the remainder of the 6 months. Participants receiving placebo will start taking the placebo maintenance dose after the first 6 weeks. For safety monitoring, 25(OH) vitamin D3 levels will also be re-measured at monthly intervals and followed by an independent medical monitor. In patients who have serum vitamin D levels 60ng/ml, the frequency of administration will be reduced to once a month. The participants will receive supplementation for a total of 6 months. At this time, vitamin D levels will be reassessed and participants will undergo follow-up functional assessments, and cognitive and immune testing.
Tracking Information
- NCT #
- NCT01229878
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James B Post, MD James J. Peters Veterans Affairs Medical Center