Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces proteins levels associated with vascular calcification (osteoprotegerin, osteopontin, osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Cholecalciferol

Criteria

Inclusion Criteria:

• Peritoneal dialysis treatment for at least 3 months.

• Concentrations of 25-oh vitamin D <20 ng / mL

• Corrected calcium <10.5 mg / dL

• Serum phosphorus <7.0 mg / dL

• Intact parathyroid hormone > 50 pg / mL and <1500 pg/mL

Exclusion Criteria:

• Active participation in another protocol.

• Vitamin D deficiency due to a hereditary disease or liver disease.

• Use of cholecalciferol ≥ 2000 IU per day within 6 months prior

• New prescription of calcitriol or paricalcitol at any dose within three months prior to the intervention (The subjects may be taking calcitriol or paricalcitol only if these drugs are taken at least three months before and no substantial changes in dosage have been made).

• Use of bisphosphonates.

• Treatment with anticonvulsants or other drugs that affect the metabolism of vitamin D.

• Pregnancy and lactation.

• Active cancer or other active inflammatory disease.

• HIV or AIDS