Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.

There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Dialysis Solutions

Criteria

Inclusion Criteria:

• Willingness to sign an informed consent

• Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session

• Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) > 150 pg/mL, hypercalcemia defined as serum Ca > 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2

Exclusion Criteria:

• Inability or unwillingness to sign the informed consent

• Cardiac arrhythmia

• Serious renal osteopathy

• Oral active vitamin D and/or calcium carbonate intolerance

• Poor compliance or unwillingness to meet the scheme demands raised by the investigators

• Patients who had undergone percutaneous ethanol injection therapy or parathyroidectomy for secondary hyperparathyroidism

• Patients who had previously been treated and/or were being treated with glucocorticoid, which affects bone metabolism.