Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient

Not yet recruiting

• Conditions: Vitamin B 12 Deficiency; End Stage Renal Disease on Dialysis

• Registration Number: NCT06441721
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06
• Study Start: 2024-07-05
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vitamin b12 in serum	one year	vitamin b12 evaluation vitamin b12 evaluation