- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633853
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
January 16, 2016 updated by: Dongliang Zhang, MD
Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines.
Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol.
A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group.
Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100050
- Beijing Friedship Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with age between 18-75 years.
- Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.
Exclusion Criteria:
- Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- New fracture in last 3 months.
- Active system immunity diseases.
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
- Primary hyperparathyroidism
- Treatment with cinacalcet or other calcimimetic within the past 6 months
- Anticipated dialysis within 6 months after randomization
- Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- Current treatment with vitamin D 50,000 IU
- Using glucocorticoid or immunosuppressive agents.
- Acute renal dysfunction.
- The expected live time is less than 2 years.
- Pregnant or lactating woman.
- Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D2 Treatment
Patients will be treated by vitamin D2.
Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
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Treatment with Vit D2.
Other Names:
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Active Comparator: 1,25(OH)2 Vitamin D3
Patients will be treated by 1,25(OH)2 Vitamin D3.
Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
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Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Blood Levels of Calcium at the 24th Month of Following up.
Time Frame: 24 months
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The blood levels of calcium at the 24th month of following up will be detected.
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24 months
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The Blood Levels of Phosphorus at the 24th Month of Following up.
Time Frame: 24 months
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The blood levels of phosphorus at the 24th month of following up will be detected.
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24 months
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The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
Time Frame: 24 months
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The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Blood 25(OH)Vitamin D Level.
Time Frame: 24 months
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The levels of blood 25(OH)Vitamin D at the 24th month of following up.
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24 months
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The Incidence Rate of Secondary Hyperparathyroidism.
Time Frame: 24 months
|
Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT.
The incidence of sHPT during following up were recorded and compared between two groups.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dongliang Zhang, Doctor, Nephrology Department of Beijing Friendship Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
June 29, 2012
First Submitted That Met QC Criteria
July 2, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
February 15, 2016
Last Update Submitted That Met QC Criteria
January 16, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Rickets
- Hyperparathyroidism, Secondary
- Hyperparathyroidism
- Kidney Diseases
- Renal Insufficiency, Chronic
- Vitamin D Deficiency
- Chronic Kidney Disease-Mineral and Bone Disorder
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 2012-078
- Z121107001012138 (OTHER_GRANT: Beijing Municipal Science and Technology Commission)
- 2011-2002-02 (Other Grant/Funding Number: The capital health research and development of special)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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