Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient

NCT ID: NCT06441721

Last Updated: 2024-06-06

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

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-05

Study Completion Date

2025-09-01

Brief Summary

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To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations

Detailed Description

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Vitamin B12 (cobalamin) is a water-soluble vitamin involved in several normal cellular functions (1). Vitamin B12 is required for the development, myelination, and function of the central nervous system; healthy red blood cell formation; and DNA synthesis (2- 4). Low levels of vitamin B12 have been associated with high concentrations of homocysteine (Hcy) and can lead to health complications (5). Hyperhomocysteinemia is an important risk factor for cardiovascular disease (6). Vitamin B12 and other B vitamins are involved in homocysteine metabolism, and researchers have hypothesized that supplementation with these micronutrients can reduce the risk of cardiovascular disease by lowering homocysteine levels (7, 8). Vitamin B12 deficiency is one of the causes of Macrocytic anaemia with increased mean corpuscular volume (MCV), defined as more than 100 fL, which is the hallmark of megaloblastic anaemia

Conditions

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End Stage Renal Disease on Dialysis Vitamin B 12 Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Vitamin b12 measure

Measure vitamin b12 in serum and its impact on Haemodialysis patient

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* End stage renal disease on haemodialysis pts.
* Parients more than 18 years .
* CKD patients controled group stage 3and stage 4.

Exclusion Criteria

* Recent renal transplantation patients.
* Patients on sulpha drugs.
* Patients on methotrexate.
* Patients on anticonvulsant.
* Patients on chemotherap agent.
* Patients on colchicine.
* Patients on bile acid sequestrant.
* Patients on h2blockers.
* Patients on metformin.
* Patients on proton pump inhibitors .
* Diabetic patients.
* Parients with history of intestinal surgery.
* Patients diagnosed with malabsorption syndrome.
* Patient on vitamin b12 intake.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Afaf Bakry Amin Omer

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Afaf bakry amin, Resident

Role: CONTACT

01093626639

Alaa Eldin Abd Elmoniem, supervisor

Role: CONTACT

0106287922

References

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Juszczak AB, Kupczak M, Konecki T. Does Vitamin Supplementation Play a Role in Chronic Kidney Disease? Nutrients. 2023 Jun 23;15(13):2847. doi: 10.3390/nu15132847.

Reference Type BACKGROUND
PMID: 37447174 (View on PubMed)

Fahndrich C, Gemperli A, Baumberger M, Harder M, Roth B, Schaefer DJ, Wettstein R, Scheel-Sailer A. Risk factors of major complications after flap surgery in the treatment of stage III and IV pressure injury in people with spinal cord injury/disorder: a retrospective cohort study. Spinal Cord. 2024 Jan;62(1):34-41. doi: 10.1038/s41393-023-00944-9. Epub 2023 Dec 20.

Reference Type RESULT
PMID: 38123748 (View on PubMed)

Related Links

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http://doi.org/10.1186/s41100-018-0149-8

Annual dialysis data report 2015 jsdt renal data

Other Identifiers

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Vitamin B12 and Haemodialysis

Identifier Type: -

Identifier Source: org_study_id

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