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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02005302
• Other study ID #: BJFH-EC/2013-076
• Secondary ID: D131100004713001
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 4, 2013
• Last updated: December 4, 2013
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2013
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Drug:
• 1,25(OH)2 Vitamin D3
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.
• 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.

Dietary Supplement:
• low protein diet
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.
• normal protein diet
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.

Locations

Country	Name	City	State
China	Beijing Friedship Hospital	Beijing	Beijing
China	Beijing XuanWu Hospital	Beijing	Beijing
China	People's Liberation Army Air Force General Hospital	Beijing	Beijing
China	People's Liberation Army General Hospital	Beijing	Beijing
China	Sino-Japanese Friendship Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Wenhu Liu	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months	No
Primary	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.	36 months	No
Secondary	The changes of the blood 25(OH)Vitamin D level		36 months	No
Secondary	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.	36 months	No