End Stage Renal Disease on DialysisHaemodialysisNCT06441721
Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient
An observational study of End Stage Renal Disease on Dialysis and Vitamin B 12 Deficiency, run by Assiut University.
Trial summary
To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Vitamin B 12 Deficiency
- What is being tested?
- Vitamin b12 measure
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years
Who may be able to join
- End stage renal disease on haemodialysis pts.
- Parients more than 18 years .
- CKD patients controled group stage 3and stage 4.
Who cannot join
- Recent renal transplantation patients.
- Patients on sulpha drugs.
- Patients on methotrexate.
- Patients on anticonvulsant.
- Patients on chemotherap agent.
- Patients on colchicine.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
Alaa Eldin Abd Elmoniem, supervisor contact
About this study
Official title: 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
Read the 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
- Being tested
- Vitamin b12 measure
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin b12 measureDevice
Measure vitamin b12 in serum and its impact on Haemodialysis patient
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin b12 in serum
vitamin b12 evaluation vitamin b12 evaluation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start5 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afaf Bakry Amin Omer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441721
- Sponsor's protocol ID
- Vitamin B12 and Haemodialysis
- Acronym
- Haemodialysis
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37447174Fahndrich 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.
PubMed 38123748
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin b12 Deficency and Its Impact on Chronic Haemodialysis Patient and Its Effect on Anemia and Neuropathy
- ClinicalTrials.gov ID
- NCT06441721
- Acronym / sponsor ID
- Haemodialysis / Vitamin B12 and Haemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years
Key inclusion criteria (3 listed)
- End stage renal disease on haemodialysis pts.
- Parients more than 18 years .
- CKD patients controled group stage 3and stage 4.
Key exclusion criteria (14 listed)
- Recent renal transplantation patients.
- Patients on sulpha drugs.
- Patients on methotrexate.
- Patients on anticonvulsant.
- Patients on chemotherap agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin b12 measureMeasure vitamin b12 in serum and its impact on Haemodialysis patient | Device | – |
Primary outcome
vitamin b12 in serum
Time frame: one year
vitamin b12 evaluation vitamin b12 evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 37447174Juszczak 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.
- Results publication: PubMed 38123748Fahndrich 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.
- Annual dialysis data report 2015 jsdt renal dataLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa Eldin Abd Elmoniem, supervisor contact
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis and Vitamin B 12 Deficiency, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afaf bakry amin, Resident (01093626639, afafbakry79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin b12 in serum (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.