Chronic Kidney Disease Stage 3 and 4 Clinical Trial
Official title:
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01020487 -
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
|
Phase 3 |