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Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition

Primary Purpose

Vitamin D Deficiency, Malnutrition

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
1,25(OH)2 Vitamin D3
Vitamin D2
low protein diet
normal protein diet
Sponsored by
Wenhu Liu
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 disease, Malnutrition, Vitamin D, low protein diet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age between 18-80 years.
  • Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition

Exclusion Criteria:

  • Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
  • 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 XuanWu Hospital
  • People's Liberation Army Air Force General Hospital
  • People's Liberation Army General Hospital
  • Sino-Japanese Friendship Hospital
  • Beijing Friedship Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Vitamin D2 Treatment

1,25(OH)2 Vitamin D3

low protein diet

normal protein diet

Arm Description

Outcomes

Primary Outcome Measures

The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
The changes on the clinical indicators of nutritional status
The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.

Secondary Outcome Measures

The changes of the blood 25(OH)Vitamin D level
The changes of the quality of life
Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline.

Full Information

First Posted
December 4, 2013
Last Updated
December 4, 2013
Sponsor
Wenhu Liu
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02005302
Brief Title
Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition
Official Title
Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenhu Liu
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.
Detailed Description
This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Malnutrition
Keywords
chronic kidney disease, mineral and bone disease, Malnutrition, Vitamin D, low protein diet

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Vitamin D2 Treatment
Arm Type
Experimental
Arm Title
1,25(OH)2 Vitamin D3
Arm Type
Active Comparator
Arm Title
low protein diet
Arm Type
Experimental
Arm Title
normal protein diet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
1,25(OH)2 Vitamin D3
Other Intervention Name(s)
Active Vit D3
Intervention Description
Oral 1,25(OH)2 Vitamin D3 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)
Vit D2
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
low protein diet
Intervention Description
Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.
Intervention Type
Dietary Supplement
Intervention Name(s)
normal protein diet
Intervention Description
Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.
Primary Outcome Measure Information:
Title
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
Description
The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
Time Frame
36 months
Title
The changes on the clinical indicators of nutritional status
Description
The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
The changes of the blood 25(OH)Vitamin D level
Time Frame
36 months
Title
The changes of the quality of life
Description
Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with age between 18-80 years. Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition Exclusion Criteria: Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system. 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
Wenhu Liu, Doctor
Organizational Affiliation
Nephrology Department of Beijing Friendship Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing XuanWu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
People's Liberation Army Air Force General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
People's Liberation Army General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Sino-Japanese Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Friedship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

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