Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Patients with chronic kidney disease on peritoneal dialysis have very low 25-(OH) vitamin D levels. Vitamin D deficiency may be involved in generalized atherosclerosis, vascular calcification and cardiovascular mortality. Among others, Osteoprotegerin (OPG) has been implicated in the pathogenesis leading up vessel calcification in this patients. Furthermore, very low levels of 25-(OH) vitamin D in peritoneal dialysis patients are associated with increased levels of OPG and high values of vascular calcification scores in x-rays.

It is unknown whether cholecalciferol supplementation in patients on peritoneal dialysis with low levels of 25-(OH) vitamin D could change the proteins associated with vascular calcification.

The objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in 25-OH vitamin D deficient peritoneal dialysis patients on circulating OPG and other osteogenic biomarkers levels during 16 weeks of intervention.

Moreover, the impact of cholecalciferol on serum calcium and phosphorus levels, Kidney Disease Quality of Life Short Form, and ultrasound characteristics of carotid arterial will be performed during the first four weeks after inclusion, and after 28 weeks postintervention.

Peritoneal dialysis patients found to have 25-(OH) vitamin D levels \<20 ng/ml will be included and will be randomized to receive either oral cholecalciferol therapy or placebo. Cholecalciferol will be administered at a daily dose of 4800 IU over a time period of 16 weeks.

All in all, 58 subjects will be included in this study.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cholecalciferol

A capsule of pulverized cholecalciferol 4800 U will be administered once a day for 16 weeks. At serum calcium levels \> 10.5 mg/dL (2.65 mmol/l) and/or at serum phosphorus levels \> 7 mg/dL (2.26 mmol/L) capsule administration will be discontinued and restarted one month after when serum calcium levels or phosphorus levels declined to \< 10.6 mg/dL and/or \<7.1 mg/dL respectively.

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

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.

Placebo

An oral placebo capsule matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for 16 weeks. At serum calcium levels \> 10.5 mg/dL (2.65 mmol/l) and/or at serum phosphorus levels \> 7 mg/dL (2.26 mmol/L) capsule administration will be discontinued and restarted one month after when serum calcium levels or phosphorus levels declined to \< 10.6 mg/dL and/or \<7.1 mg/dL respectively.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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"Valmetrol-3" (Capsule similar to Cholecalciferol)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No