NCT06441721

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 6, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 29, 2024

Last Update Submit

June 4, 2024

Conditions

End Stage Renal Disease on DialysisVitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (1)

  • vitamin b12 in serum

    vitamin b12 evaluation vitamin b12 evaluation

    one year

Interventions

Vitamin b12 measureDEVICE

Measure vitamin b12 in serum and its impact on Haemodialysis patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 37447174BACKGROUND

  • 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.

    PMID: 38123748RESULT

Related Links

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Afaf bakry amin, Resident

CONTACT

01093626639afafbakry79@gmail.com

Alaa Eldin Abd Elmoniem, supervisor

CONTACT

0106287922

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 4, 2024

Study Start

July 5, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

June 6, 2024

Record last verified: 2024-05