Vitamin D Deficiency Clinical Trial
Official title:
Effects of Cholecalciferol on Osteoprotegerin Levels and Other Clinical Outcomes in Chronic Kidney Disease Patients on Peritoneal Dialysis: a Randomized Controlled Trial
Verified date | March 2017 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 58 |
Est. completion date | June 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | National Medical Science and Nutrition Institute Salvador Zubiran MEXICO | Mexico | Mexico city |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
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. — View Citation
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): — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Relative reduction in circulating intact fibroblast growth factor 23 (FGF23) levels (in pg/mL) | The concentrations of intact FGF-23 will be assessed using ELISA (Austin, Texas, USA) | 16 weeks | |
Secondary | Relative reduction in circulating osteopontin (OPN) levels (in pg/mL) | The concentrations of OPN will be assessed using ELISA (Austin, Texas, USA) | 16 weeks | |
Secondary | Relative reduction in circulating osteocalcin (OCN) levels (in pg/mL) | The concentrations of OCN will be assessed using ELISA ( Austin, Texas, USA) | 16 weeks | |
Secondary | 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. | 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. | 52 weeks | |
Secondary | Number of participants with courses of corrected calcium (>10.5 mg/dL) and phosphorus (>7 mg/dL) levels | During follow-up, all participants will be interviewed. All participants will be interviewed and a blood sample will be taken every 4-6 weeks. | 16 weeks |
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