Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient

End Stage Renal Disease on Dialysis Clinical Trial

— Haemodialysis  

Official title:

Vitamin b12 Deficency and Its Impact on Chronic Haemodialysis Patient and Its Effect on Anemia and Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441721
• Other study ID #: Vitamin B12 and Haemodialysis
• Status: Not yet recruiting
• Start date: July 5, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Afaf bakry amin, Resident
• Phone: 01093626639
• Email: afafbakry79[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2025
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic
• Vitamin B 12 Deficiency

Intervention

Device:
• Vitamin b12 measure
Measure vitamin b12 in serum and its impact on Haemodialysis patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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 r — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin b12 in serum	vitamin b12 evaluation vitamin b12 evaluation	one year

External Links

•   Annual dialysis data report 2015 jsdt renal data