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

This study has been completed.
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Dongliang Zhang, MD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01633853
First received: June 29, 2012
Last updated: January 16, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Vitamin D Deficiency
Drug: Vitamin D2
Drug: 1,25(OH)2 Vit D3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • The Blood Levels of Calcium at the 24th Month of Following up. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The blood levels of calcium at the 24th month of following up will be detected.

  • The Blood Levels of Phosphorus at the 24th Month of Following up. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The blood levels of phosphorus at the 24th month of following up will be detected.

  • The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.


Secondary Outcome Measures:
  • The Blood 25(OH)Vitamin D Level. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The levels of blood 25(OH)Vitamin D at the 24th month of following up.

  • The Incidence Rate of Secondary Hyperparathyroidism. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 204
Study Start Date: July 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633853

Locations
China, Beijing
Beijing Friedship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Dongliang Zhang, MD
Beijing Municipal Science & Technology Commission
Investigators
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  2011-2002-02 
Study First Received: June 29, 2012
Results First Received: October 21, 2015
Last Updated: January 16, 2016
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by 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
Urologic Diseases
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcitriol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 23, 2016