Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02598635
• Date of registration: 31/10/2015
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Public title: Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
• Scientific title: Effects of Cholecalciferol on Osteoprotegerin Levels and Other Clinical Outcomes in Chronic Kidney Disease Patients on Peritoneal Dialysis: a Randomized Controlled Trial
• Date of first enrolment: October 2015
• Target sample size: 58
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02598635
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Ricardo Correa-Rotter, MD
• Affiliation: Head Dept Nephrology and Mineral Metabolism National Medical Science and Nutrition Institute Salvador Zubiran MEXICO

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Renal Insufficiency

Vitamin D Deficiency

End Stage Renal Failure on Dialysis

Vascular Calcification

Intervention(s)

Drug: Placebo

Drug: Cholecalciferol

Primary Outcome(s)

Relative reduction in serum osteoprotegerin (OPG) levels assessed by ELISA (in pg/mL) between study inclusion, and the 16-week intervention period. [Time Frame: 16 weeks]

Secondary Outcome(s)

Relative reduction in circulating osteopontin (OPN) levels (in pg/mL) [Time Frame: 16 weeks]

Relative reduction in circulating intact fibroblast growth factor 23 (FGF23) levels (in pg/mL) [Time Frame: 16 weeks]

Number of participants with courses of corrected calcium (>10.5 mg/dL) and phosphorus (>7 mg/dL) levels [Time Frame: 16 weeks]

Relative reduction in circulating osteocalcin (OCN) levels (in pg/mL) [Time Frame: 16 weeks]

Relative reduction in intima-media thickness measurements in the carotid artery. Ultrasound examination will be performed at study inclusion, at 16 weeks after inclusion, and up to 52 weeks post inclusion. [Time Frame: 52 weeks]

Secondary ID(s)

1419

Source(s) of Monetary Support

Please refer to primary and secondary sponsors