Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00958451 |
Recruitment Status :
Completed
First Posted : August 13, 2009
Last Update Posted : March 24, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Hyperparathyroidism Chronic Kidney Disease | Drug: Paricalcitol Drug: Ergocalciferol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Response of Secondary Hyperparathyroidism to Paricalcitol Versus Ergocalciferol in Patients With Stage 3 and 4 Chronic Kidney Disease With Vitamin D Deficiency: a Randomized Controlled Trial |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Paricalcitol
Arm 1: 40 patients will be assigned to paricalcitol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.
|
Drug: Paricalcitol
Drug: Ergocalciferol
|
Active Comparator: Ergocalciferol
Arm 2: 40 patients will be assigned to the Ergocalciferol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.
|
Drug: Paricalcitol
Drug: Ergocalciferol
|
- To achieve 2 consecutive iPTH measurements with 30% or greater decrease from baseline [ Time Frame: 2 years ]
- To achieve 25OHD level above 30 ng/ml and change cardiovascular markers [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female chronic kidney disease patients at least 18 years of age.
- Patients should be able and willing to provide written informed consent and HIPAA Authorization.
- Chronic kidney disease stage 3 or 4.
- Plasma intactPTH level above 75pg/ml.
- Serum 25 OHD level below 30ng/ml.
- Negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy.
- Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior to screening.
Exclusion Criteria:
- Women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control.
- Patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study.
- Major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery).
- Patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years.
- Patients with a medical status that the PI decides would preclude participation.
- Patients on hemodialysis or peritoneal dialysis.
- Patients with a functional renal transplant.
- Patients with allergies to study drugs.
- Patients with acute renal failure with the past 12 weeks.
- Patients with clinically significant gastrointestinal or liver disease.
- Patients with active granulomatous disease.
- Patients with urine calcium:creatinine ratio of more than 0.2.
- Patients who received vitamin D analogs, calcimimetics, or biphosphonates within 4 weeks before screening. Treatment with any one of these medicines during the study is not permitted.

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): NCT00958451
United States, Virginia | |
VA Medical Center | |
Salem, Virginia, United States, 24153 |
Principal Investigator: | Csaba P. Kovesdy, M.D. | Salem VAMC |
Responsible Party: | Csaba P. Kovesdy, M.D., Salem VAMC |
ClinicalTrials.gov Identifier: | NCT00958451 |
Other Study ID Numbers: |
CK0023 |
First Posted: | August 13, 2009 Key Record Dates |
Last Update Posted: | March 24, 2011 |
Last Verified: | August 2009 |
Calcium Vitamin D deficiency Chronic Kidney disease |
Neoplasm Metastasis Kidney Diseases Renal Insufficiency, Chronic Vitamin D Deficiency Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Neoplastic Processes Neoplasms Pathologic Processes Renal Insufficiency Avitaminosis Deficiency Diseases |
Malnutrition Nutrition Disorders Parathyroid Diseases Endocrine System Diseases Ergocalciferols Vitamin D Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |