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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vitamin D2
1,25(OH)2 Vit D3
Sponsored by
Dongliang Zhang, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring chronic kidney disease mineral and bone disorder, vitamin D2, parathyroid hormone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Friedship Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin D2 Treatment

1,25(OH)2 Vitamin D3

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Blood Levels of Calcium at the 24th Month of Following up.
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.
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.
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.
The levels of blood 25(OH)Vitamin D at the 24th month of following up.
The Incidence Rate of Secondary Hyperparathyroidism.
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.

Full Information

First Posted
June 29, 2012
Last Updated
January 16, 2016
Sponsor
Dongliang Zhang, MD
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01633853
Brief Title
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dongliang Zhang, MD
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
chronic kidney disease mineral and bone disorder, vitamin D2, parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D2 Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
1,25(OH)2 Vitamin D3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
Vitamin D2 soft capsules
Intervention Description
Treatment with Vit D2.
Intervention Type
Drug
Intervention Name(s)
1,25(OH)2 Vit D3
Other Intervention Name(s)
Rocaltrol
Intervention Description
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Primary Outcome Measure Information:
Title
The Blood Levels of Calcium at the 24th Month of Following up.
Description
The blood levels of calcium at the 24th month of following up will be detected.
Time Frame
24 months
Title
The Blood Levels of Phosphorus at the 24th Month of Following up.
Description
The blood levels of phosphorus at the 24th month of following up will be detected.
Time Frame
24 months
Title
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
Description
The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The Blood 25(OH)Vitamin D Level.
Description
The levels of blood 25(OH)Vitamin D at the 24th month of following up.
Time Frame
24 months
Title
The Incidence Rate of Secondary Hyperparathyroidism.
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongliang Zhang, Doctor
Organizational Affiliation
Nephrology Department of Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friedship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

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

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