Keto-/Amino Acid Supplemented Low Protein Diet in Patients With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT00364884|
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 16, 2006
Last Update Posted : August 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: ketoaminoacid||Phase 4|
Fifty patients will be included into the study. The study comprises 9 visits. The treatment period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period. Patients are required to visit the investigator two times before the start of active treatment.
All patients who are qualified for this study will then be randomised by receiving their medication/introduction of dietary management using the standard simple randomization method.Group I patients will receive keto-/amino acid (Ketosteril) supplemented low protein diet during the active treatment period while Group II patients will receive non-supplemented low protein diet during the same period. The daily dose of keto-/amino acid for each Group I patient is one tablet every 5 kg body weight. The total daily dose will be divided into three times a day.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Effects Between Keto-/Amino Acid Supplemented Low Protein Diet and Non-Supplemented Low Protein Diet in Patients With Stage Ⅴ Chronic Kidney Disease|
|Study Start Date :||August 2006|
|Study Completion Date :||August 2007|
- Glomerular filtration rate (GFR) and creatinine clearance (Ccr)
- 1. Hemodynamics, 2. Biochemistry status, 3. Bone density analysis, 4. Nutritional status, 5. Urinary status, 6. Compliance check, 7. Incidence of Aes8. Health-related quality of life, 9. Economic benefit
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): NCT00364884
|Contact: Kao Tze-Wah, MD, Master||886-2-23123456 ext firstname.lastname@example.org|
|Principal Investigator:||Kao Tze-Wah, MD, Master||National Taiwan University Hospital|