Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient (Haemodialysis)
June 4, 2024 updated by: Afaf Bakry Amin Omer, Assiut University
Vitamin b12 Deficency and Its Impact on Chronic Haemodialysis Patient and Its Effect on Anemia and Neuropathy
To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Afaf bakry amin, Resident
- Phone Number: 01093626639
- Email: afafbakry79@gmail.com
Study Contact Backup
- Name: Alaa Eldin Abd Elmoniem, supervisor
- Phone Number: 0106287922
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vitamin b12 in serum
Time Frame: one year
|
vitamin b12 evaluation vitamin b12 evaluation
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 5, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
May 29, 2024
First Submitted That Met QC Criteria
May 29, 2024
First Posted (Actual)
June 4, 2024
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 4, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Renal Insufficiency, Chronic
- Vitamin B Deficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Failure, Chronic
- Vitamin B 12 Deficiency
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Hematinics
- Vitamin B 12
- Hydroxocobalamin
Other Study ID Numbers
- Vitamin B12 and Haemodialysis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.