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Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

2014-08-27 03:20:03 | BioPortfolio

Summary

This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.

Description

This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines. Patients will be randomized to receive oral daily ergocalciferol or paricalcitol. A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Secondary Hyperparathyroidism

Intervention

Paricalcitol, Ergocalciferol

Location

VA Medical Center
Salem
Virginia
United States
24153

Status

Recruiting

Source

Salem Veterans Affairs Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:03-0400

Clinical Trials [191 Associated Clinical Trials listed on BioPortfolio]

Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

The purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the alread...

Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease subjects receiving hemodialysis with secon...

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have...

Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism

The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney dise...

Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in moderate to severe SHPT subjects under hemodialysis who are calcitriol-resistant.

PubMed Articles [3691 Associated PubMed Articles listed on BioPortfolio]

Identification of Differential Transcriptional Patterns in Primary and Secondary Hyperparathyroidism.

Hyperparathyroidism is associated with hypercalcemia and the excess of parathyroid hormone secretion. However, the alterations in molecular pattern of functional genes during parathyroid tumorigenesis...

Paricalcitol and Peritoneal Protein Loss in Peritoneal Dialysis: A Double-Center Study.

Peritoneal protein loss (PPL) is associated with cardiovascular disease and mortality in peritoneal dialysis (PD). Controversial results have been published about the effect of paricalcitol in PPL amo...

Severe secondary hyperparathyroidism in patients on haemodialysis is associated with a high initial serum parathyroid hormone and beta-CrossLaps level: Results from an incident cohort.

Secondary hyperparathyroidism (SHPT) is a frequent complication of renal disease and most commonly occurs in patients on haemodialysis (HD) with metabolic, vascular, endocrine, and bone complications....

Therapeutic experience of severe and recurrent secondary hyperparathyroidism in a patient on hemodialysis for 18 years: A case report.

For patients with refractory secondary hyperparathyroidism (SHPT), parathyroidectomy (PTX) has received increasing attention. However, evidence-based medicine shows that there is still controversy reg...

Ischemic Stroke in the Setting of Secondary Hyperparathyroidism Due to Vitamin D Deficiency: Running Title: Ischemic Stroke and Hyperparathyroidism.

Medical and Biotech [MESH] Definitions

A condition of abnormally elevated output of PARATHYROID HORMONE (or PTH) triggering responses that increase blood CALCIUM. It is characterized by HYPERCALCEMIA and BONE RESORPTION, eventually leading to bone diseases. PRIMARY HYPERPARATHYROIDISM is caused by parathyroid HYPERPLASIA or PARATHYROID NEOPLASMS. SECONDARY HYPERPARATHYROIDISM is increased PTH secretion in response to HYPOCALCEMIA, usually caused by chronic KIDNEY DISEASES.

Abnormally elevated PARATHYROID HORMONE secretion as a response to HYPOCALCEMIA. It is caused by chronic KIDNEY FAILURE or other abnormalities in the controls of bone and mineral metabolism, leading to various BONE DISEASES, such as RENAL OSTEODYSTROPHY.

Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.

Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.

Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.

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