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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease stage3

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 14, 2020
    Last Updated
    May 12, 2020
    Sponsor
    Assiut University
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    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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