Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous
Primary Purpose
Chronic Kidney Disease stage3
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Activated charcoal
Dry seeds
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease stage3
Eligibility Criteria
Inclusion Criteria:
Patients with CKD stages iii and iv
Patients with age more than 18 years old
Exclusion Criteria:
Patients on regular hemodialysis
Patients with age less than 18 years old
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
No Intervention
Arm Label
1st group
2nd group
3rd group
Arm Description
Oral activated charcoal in a dose of 30 gm/day
Dry seeds in a dose of 1 gm/ day
control group
Outcomes
Primary Outcome Measures
Mean of blood urea, creatinine and phosphorous in patients with CKD before and after oral activated charcoal
to asses the mean of blood urea, creatinine and phosphorous in CKD patient before and after administration of activated charcoal
Secondary Outcome Measures
comparison of dry seeds and activated charcoal in limitting progression of chronic kidney disease
To compare dry seeds with activated charcoal as as alternative natural cheap methods that may help in limitting progression of CKD by measuring blood urea, creatinine, and phosphorous in all 3 groups of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04311645
Brief Title
Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous
Official Title
Role of Oral Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to explore the ability of Oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with CKD stages III and IV.
To compare its effect with the effect of dry seeds as absorbents of uremic toxins
Detailed Description
In recent years, chronic kidney disease(CKD) has become a worldwide public health issue.
The main factors affecting the prognosis of patients with chronic kidney disease are its complications, including cardiovascular and cerebrovascular diseases, malnutrition, inflammation, atherosclerosis syndrome, and anemia.
The accumulation of uremic toxins, such as indoxyl sulfate and p-cresyl sulfate, is implicated in the progression of renal failure and cardiovascular disease.
For many patients, chronic kidney disease (CKD) is a progressive condition marked by deteriorating renal function ultimately leading to end-stage renal disease (ESRD) and many patients refuse to start chronic hemodialysis.
Therapeutic approaches that decrease the level of uremic toxins are a rational method for inhibiting this progression.
Many researches have been done aiming to find alternatives for chronic hemodialysis either for economic issues or psychological issues especially in elderly patients, as example:
Gum Arabic in the remedy and amelioration of kidney dysfunction and end-stage renal disease
skin as excretory root for urea, increasing sweat from sweat glands can support kidney function by excreting a good amount of what kidneys naturally excrete.
The oral charcoal adsorbent reduces serum levels of indoxyl sulfate through adsorption of indole converted from dietary tryptophan in the gastrointestinal tract decreasing serum creatinine and urea level .
In this study, the clinical data supporting the role of oral activated charcoal in a dose of 30gm/ day for slowing the progression of CKD will be reviewed.
In this study, a trial will be done using dry seeds (lentils as an example) as an absorbent for uremic toxins comparing its effect with the effect of oral activated charcoal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1st group
Arm Type
Other
Arm Description
Oral activated charcoal in a dose of 30 gm/day
Arm Title
2nd group
Arm Type
Other
Arm Description
Dry seeds in a dose of 1 gm/ day
Arm Title
3rd group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
Activated charcoal
Intervention Description
Activated charcoal
Intervention Type
Dietary Supplement
Intervention Name(s)
Dry seeds
Intervention Description
Dry seeds
Primary Outcome Measure Information:
Title
Mean of blood urea, creatinine and phosphorous in patients with CKD before and after oral activated charcoal
Description
to asses the mean of blood urea, creatinine and phosphorous in CKD patient before and after administration of activated charcoal
Time Frame
baseline
Secondary Outcome Measure Information:
Title
comparison of dry seeds and activated charcoal in limitting progression of chronic kidney disease
Description
To compare dry seeds with activated charcoal as as alternative natural cheap methods that may help in limitting progression of CKD by measuring blood urea, creatinine, and phosphorous in all 3 groups of the study
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with CKD stages iii and iv
Patients with age more than 18 years old
Exclusion Criteria:
Patients on regular hemodialysis
Patients with age less than 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
farrag s mohamed
Phone
01143681697
Email
faragsayed99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf A Al-Shazly, Prof
12. IPD Sharing Statement
Citations:
PubMed Identifier
18182793
Citation
Brunori G, Viola BF, Maiorca P, Cancarini G. How to manage elderly patients with chronic renal failure: conservative management versus dialysis. Blood Purif. 2008;26(1):36-40. doi: 10.1159/000110561. Epub 2008 Jan 10.
Results Reference
background
PubMed Identifier
20797565
Citation
Niwa T. Indoxyl sulfate is a nephro-vascular toxin. J Ren Nutr. 2010 Sep;20(5 Suppl):S2-6. doi: 10.1053/j.jrn.2010.05.002.
Results Reference
background
PubMed Identifier
1906999
Citation
Niwa T, Emoto Y, Maeda K, Uehara Y, Yamada N, Shibata M. Oral sorbent suppresses accumulation of albumin-bound indoxyl sulphate in serum of haemodialysis patients. Nephrol Dial Transplant. 1991;6(2):105-9. doi: 10.1093/ndt/6.2.105.
Results Reference
background
PubMed Identifier
29279852
Citation
Xie L, Jin L, Feng J, Lv J. The Expression of AQP5 and UTs in the Sweat Glands of Uremic Patients. Biomed Res Int. 2017;2017:8629783. doi: 10.1155/2017/8629783. Epub 2017 Nov 27.
Results Reference
background
PubMed Identifier
11641313
Citation
Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.
Results Reference
background
PubMed Identifier
19478096
Citation
Mizobuchi M, Towler D, Slatopolsky E. Vascular calcification: the killer of patients with chronic kidney disease. J Am Soc Nephrol. 2009 Jul;20(7):1453-64. doi: 10.1681/ASN.2008070692. Epub 2009 May 28.
Results Reference
background
PubMed Identifier
16307356
Citation
Cook WL, Jassal SV. Prevalence of falls among seniors maintained on hemodialysis. Int Urol Nephrol. 2005;37(3):649-52. doi: 10.1007/s11255-005-0396-9.
Results Reference
background
PubMed Identifier
17283348
Citation
Kurella M, Covinsky KE, Collins AJ, Chertow GM. Octogenarians and nonagenarians starting dialysis in the United States. Ann Intern Med. 2007 Feb 6;146(3):177-83. doi: 10.7326/0003-4819-146-3-200702060-00006.
Results Reference
background
PubMed Identifier
8957051
Citation
Friedman EA. Bowel as a kidney substitute in renal failure. Am J Kidney Dis. 1996 Dec;28(6):943-50. doi: 10.1016/s0272-6386(96)90399-6.
Results Reference
background
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Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous
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