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Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT02598635
Recruitment Status : Unknown
Verified March 2017 by Juan C Ramirez-Sandoval, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2015
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Juan C Ramirez-Sandoval, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Vascular Calcification Renal Insufficiency End Stage Renal Failure on Dialysis Drug: Cholecalciferol Drug: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Cholecalciferol on Osteoprotegerin Levels and Other Clinical Outcomes in Chronic Kidney Disease Patients on Peritoneal Dialysis: a Randomized Controlled Trial
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: "Valmetrol-3"

Placebo Comparator: 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.
Drug: Placebo
An oral placebo capsule matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for 16 weeks.
Other Name: (Capsule similar to Cholecalciferol)




Primary Outcome Measures :
  1. 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 ]
    The concentrations of OPG will be assessed using ELISA (Austin, Texas, USA) at inclusion and after 16 weeks of treatment with cholecalciferol or placebo.Minimum detectable concentrations for OPG are 1.9 pg/mL; intra and inter-assay coefficients of variability are 5% and 11% for OPG.


Secondary Outcome Measures :
  1. Relative reduction in circulating intact fibroblast growth factor 23 (FGF23) levels (in pg/mL) [ Time Frame: 16 weeks ]
    The concentrations of intact FGF-23 will be assessed using ELISA (Austin, Texas, USA)

  2. Relative reduction in circulating osteopontin (OPN) levels (in pg/mL) [ Time Frame: 16 weeks ]
    The concentrations of OPN will be assessed using ELISA (Austin, Texas, USA)

  3. Relative reduction in circulating osteocalcin (OCN) levels (in pg/mL) [ Time Frame: 16 weeks ]
    The concentrations of OCN will be assessed using ELISA ( Austin, Texas, USA)

  4. 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 ]
    Ultrasound examination will be performed with the use of an 8-megahertz annular array ultrasound imaging system by a single trained sonographer. With this technique, 2 parallel echogenic lines separated by an anechoic space can be visualized at levels of the artery wall. The distance between the 2 lines gives a reliable index of the thickness of the intimal-medial complex. Subjects will be examined in the supine position. Ultrasound scans of the right and left last distal centimeter of common carotid arteries and bifurcation and of the first proximal centimeter of internal carotid arteries in 3 different projections (anterior, lateral, and posterior) will be performed. All measurements will be made at the time of scanning on unfrozen images of longitudinal scans by using the machine's electronic caliper.

  5. Number of participants with courses of corrected calcium (>10.5 mg/dL) and phosphorus (>7 mg/dL) levels [ Time Frame: 16 weeks ]
    During follow-up, all participants will be interviewed. All participants will be interviewed and a blood sample will be taken every 4-6 weeks.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598635


Locations
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Mexico
National Medical Science and Nutrition Institute Salvador Zubiran MEXICO
Mexico, Mexico city, Mexico, 01400
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Study Director: Ricardo Correa-Rotter, MD Head Dept Nephrology and Mineral Metabolism National Medical Science and Nutrition Institute Salvador Zubiran MEXICO

Publications of Results:
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Responsible Party: Juan C Ramirez-Sandoval, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02598635     History of Changes
Other Study ID Numbers: 1419
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by Juan C Ramirez-Sandoval, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Cholecalciferol
peritoneal dialysis
FGF23
Calcium
Phosphorus
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Vitamin D Deficiency
Vascular Calcification
Kidney Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Cholecalciferol
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vitamins
Micronutrients
Nutrients
Growth Substances