MedTrace Logo

Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

NCT02598635 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-03-24

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Vascular Calcification
  • Renal Insufficiency
  • End Stage Renal Failure on Dialysis

Interventions

DRUG

Cholecalciferol

Patients on peritoneal dialysis and 25-(OH) levels \<20 ng/mL will received one capsule of cholecalciferol (4800 U) once a day for 16 weeks.

DRUG

Placebo

An oral placebo capsule matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for 16 weeks.

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-10-31
Completion
2017-06-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598635 on ClinicalTrials.gov