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Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder

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ClinicalTrials.gov Identifier: NCT01633853
Recruitment Status : Completed
First Posted : July 4, 2012
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D2 Drug: 1,25(OH)2 Vit D3 Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
Study Start Date : July 2012
Primary Completion Date : September 2015
Study Completion Date : September 2015

Arms and Interventions

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.
Drug: Vitamin D2
Treatment with Vit D2.
Other Name: Vitamin D2 soft capsules
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.
Drug: 1,25(OH)2 Vit D3
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Other Name: Rocaltrol

Outcome Measures

Primary Outcome Measures :
  1. The Blood Levels of Calcium at the 24th Month of Following up. [ Time Frame: 24 months ]
    The blood levels of calcium at the 24th month of following up will be detected.

  2. The Blood Levels of Phosphorus at the 24th Month of Following up. [ Time Frame: 24 months ]
    The blood levels of phosphorus at the 24th month of following up will be detected.

  3. The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up. [ Time Frame: 24 months ]
    The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.

Secondary Outcome Measures :
  1. The Blood 25(OH)Vitamin D Level. [ Time Frame: 24 months ]
    The levels of blood 25(OH)Vitamin D at the 24th month of following up.

  2. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01633853

China, Beijing
Beijing Friedship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Dongliang Zhang, MD
Beijing Municipal Science & Technology Commission
Principal Investigator: Dongliang Zhang, Doctor Nephrology Department of Beijing Friendship Hospital
More Information

Responsible Party: Dongliang Zhang, MD, Associate Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01633853     History of Changes
Other Study ID Numbers: 2012-078
Z121107001012138 ( Other Grant/Funding Number: Beijing Municipal Science and Technology Commission )
2011-2002-02 ( Other Grant/Funding Number: The capital health research and development of special )
First Posted: July 4, 2012    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016

Keywords provided by Dongliang Zhang, MD, Capital Medical University:
chronic kidney disease mineral and bone disorder
vitamin D2
parathyroid hormone

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists