Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

NCT02598635 | Unknown Phase 4 DMC

• 1 other identifier: 1419
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cholecalciferol; peritoneal dialysis; FGF23; Calcium; Phosphorus

Outcome Measures

Primary Outcomes (1)

• Relative reduction in serum osteoprotegerin (OPG) levels assessed by ELISA (in pg/mL) between study inclusion, and the 16-week intervention period.

  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.

  16 weeks

Secondary Outcomes (5)

• Relative reduction in circulating intact fibroblast growth factor 23 (FGF23) levels (in pg/mL)

  16 weeks

• Relative reduction in circulating osteopontin (OPN) levels (in pg/mL)

  16 weeks

• Relative reduction in circulating osteocalcin (OCN) levels (in pg/mL)

  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.

  52 weeks

• Number of participants with courses of corrected calcium (>10.5 mg/dL) and phosphorus (>7 mg/dL) levels

  16 weeks

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Cholecalciferol 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.

Also known as: "Valmetrol-3"

Cholecalciferol

Placebo DRUG

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

Also known as: (Capsule similar to Cholecalciferol)

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

National Medical Science and Nutrition Institute Salvador Zubiran MEXICO

Mexico City, Mexico City, 01400, Mexico

Location

Related Publications (5)

• Ramirez-Sandoval JC, Casanova I, Villar A, Gomez FE, Cruz C, Correa-Rotter R. Biomarkers Associated with Vascular Calcification in Peritoneal Dialysis. Perit Dial Int. 2016 May-Jun;36(3):262-8. doi: 10.3747/pdi.2014.00250. Epub 2015 Aug 20.

  PMID: 26293840 RESULT

• Ammirati AL, Dalboni MA, Cendoroglo M, Draibe SA, Santos RD, Miname M, Canziani ME. The progression and impact of vascular calcification in peritoneal dialysis patients. Perit Dial Int. 2007 May-Jun;27(3):340-6.

  PMID: 17468488 RESULT

• Bhan I, Dobens D, Tamez H, Deferio JJ, Li YC, Warren HS, Ankers E, Wenger J, Tucker JK, Trottier C, Pathan F, Kalim S, Nigwekar SU, Thadhani R. Nutritional vitamin D supplementation in dialysis: a randomized trial. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):611-9. doi: 10.2215/CJN.06910714. Epub 2015 Mar 13.

  PMID: 25770176 RESULT

• Van Campenhout A, Golledge J. Osteoprotegerin, vascular calcification and atherosclerosis. Atherosclerosis. 2009 Jun;204(2):321-9. doi: 10.1016/j.atherosclerosis.2008.09.033. Epub 2008 Oct 9.

  PMID: 19007931 RESULT

• Janda K, Krzanowski M, Chowaniec E, Kusnierz-Cabala B, Dumnicka P, Krasniak A, Podolec P, Sulowicz W. Osteoprotegerin as a marker of cardiovascular risk in patients on peritoneal dialysis. Pol Arch Med Wewn. 2013;123(4):149-55. doi: 10.20452/pamw.1678. Epub 2013 Mar 26.

  PMID: 23535831 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Vascular Calcification; Renal Insufficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ricardo Correa-Rotter, MD

  Head Dept Nephrology and Mineral Metabolism National Medical Science and Nutrition Institute Salvador Zubiran MEXICO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: November 6, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

ME (1)