Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD
NCT ID: NCT05952544
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2023-07-20
2024-05-15
Brief Summary
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Detailed Description
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several clinical trials have documented that very low protein diets (VLPD) supplemented with KA/EAA preserve the rate of progression of advanced CKD. However, in long-term follow-up of the MDRD study, VLPD plus KA/EAA treatment did not delay progression to dialysis or transplantation.
As a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with KA/EAA supplements in retarding CKD progression.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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control group
include patients who were on low protein diet only
low protein diet
patients were on low protein diet only
interventional group
include patients who consumed KA/EAA plus very low protein diet
essential amino acids and keto-analogues supplementation
very low protein diet plus essential amino acids and keto-analogues supplementation
Interventions
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essential amino acids and keto-analogues supplementation
very low protein diet plus essential amino acids and keto-analogues supplementation
low protein diet
patients were on low protein diet only
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Protein energy wasting
3. Advanced organ disease
4. pregnancy
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Principal Investigators
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Mohamed Mamdouh Elsayed, MD
Role: PRINCIPAL_INVESTIGATOR
lecturer
Bassant Sabry
Role: STUDY_CHAIR
pharmacist
Alaa Soliman
Role: STUDY_CHAIR
pharmacist
Mohamed A. Mekawy
Role: STUDY_CHAIR
pharmacist
Engy Emam
Role: STUDY_CHAIR
Clinical Pharmacist
Locations
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Faculty of Medicine, Aexandria University
Alexandria, , Egypt
Countries
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References
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Feiten SF, Draibe SA, Watanabe R, Duenhas MR, Baxmann AC, Nerbass FB, Cuppari L. Short-term effects of a very-low-protein diet supplemented with ketoacids in nondialyzed chronic kidney disease patients. Eur J Clin Nutr. 2005 Jan;59(1):129-36. doi: 10.1038/sj.ejcn.1602050.
Gao X, Huang L, Grosjean F, Esposito V, Wu J, Fu L, Hu H, Tan J, He C, Gray S, Jain MK, Zheng F, Mei C. Low-protein diet supplemented with ketoacids reduces the severity of renal disease in 5/6 nephrectomized rats: a role for KLF15. Kidney Int. 2011 May;79(9):987-96. doi: 10.1038/ki.2010.539. Epub 2011 Jan 19.
Jiang Z, Zhang X, Yang L, Li Z, Qin W. Effect of restricted protein diet supplemented with keto analogues in chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2016 Mar;48(3):409-18. doi: 10.1007/s11255-015-1170-2. Epub 2015 Nov 30.
Menon V, Kopple JD, Wang X, Beck GJ, Collins AJ, Kusek JW, Greene T, Levey AS, Sarnak MJ. Effect of a very low-protein diet on outcomes: long-term follow-up of the Modification of Diet in Renal Disease (MDRD) Study. Am J Kidney Dis. 2009 Feb;53(2):208-17. doi: 10.1053/j.ajkd.2008.08.009. Epub 2008 Oct 31.
Other Identifiers
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effect of EAA/KA on GFR in CKD
Identifier Type: -
Identifier Source: org_study_id
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