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

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ClinicalTrials.gov Identifier: NCT02005302
Recruitment Status : Unknown
Verified December 2013 by Wenhu Liu, Beijing Friendship Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Wenhu Liu, Beijing Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Malnutrition Drug: 1,25(OH)2 Vitamin D3 Drug: Vitamin D2 Dietary Supplement: low protein diet Dietary Supplement: normal protein diet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin D2 Treatment Drug: 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.
Other Name: Vit D2

Active Comparator: 1,25(OH)2 Vitamin D3 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.
Other Name: Active Vit D3

Experimental: low protein diet 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.

Active Comparator: normal protein diet Dietary Supplement: 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.




Primary Outcome Measures :
  1. The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months [ Time Frame: 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.

  2. The changes on the clinical indicators of nutritional status [ Time Frame: 36 months ]
    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 :
  1. The changes of the blood 25(OH)Vitamin D level [ Time Frame: 36 months ]
  2. The changes of the quality of life [ Time Frame: 36 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02005302


Locations
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China, Beijing
Beijing XuanWu Hospital
Beijing, Beijing, China, 100000
People's Liberation Army Air Force General Hospital
Beijing, Beijing, China, 100000
People's Liberation Army General Hospital
Beijing, Beijing, China, 100000
Sino-Japanese Friendship Hospital
Beijing, Beijing, China, 100000
Beijing Friedship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Wenhu Liu
Beijing Municipal Science & Technology Commission
Investigators
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Principal Investigator: Wenhu Liu, Doctor Nephrology Department of Beijing Friendship Hospita

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Responsible Party: Wenhu Liu, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02005302     History of Changes
Other Study ID Numbers: BJFH-EC/2013-076
D131100004713001 ( Other Grant/Funding Number: Beijing Municipal Science and Technology Commission )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Wenhu Liu, Beijing Friendship Hospital:
chronic kidney disease
mineral and bone disease
Malnutrition
Vitamin D
low protein diet

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Malnutrition
Vitamin D Deficiency
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Nutrition Disorders
Avitaminosis
Deficiency Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamin A
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents