Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous

NCT ID: NCT04311645

Last Updated: 2020-05-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease stage3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1st group

Oral activated charcoal in a dose of 30 gm/day

Group Type OTHER

Activated charcoal

Intervention Type DRUG

Activated charcoal

2nd group

Dry seeds in a dose of 1 gm/ day

Group Type OTHER

Dry seeds

Intervention Type DIETARY_SUPPLEMENT

Dry seeds

3rd group

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Activated charcoal

Activated charcoal

Intervention Type DRUG

Dry seeds

Dry seeds

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Farrag Sayed Mohamed

Resident Doctor, internal medicine department, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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farrag s mohamed

Role: CONTACT

01143681697

Ashraf A Al-Shazly, Prof

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 18182793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20797565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1906999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29279852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11641313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19478096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16307356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17283348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8957051 (View on PubMed)

Other Identifiers

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Charcoal CKD progression

Identifier Type: -

Identifier Source: org_study_id

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