NCT01173848

Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.

Detailed description

Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group. The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.

Conditions

• Chronic Kidney Disease Stage 3 and 4

Interventions

Type	Name	Description
DRUG	Ergocalciferol	1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months
DRUG	Cholecalciferol	1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-09-01
• Completion: 2011-10-18
• First posted: 2010-08-02
• Last updated: 2017-04-04
• Results posted: 2017-04-04

Locations

1 site across 1 country: United States