MedTrace Logo

Oral Versus Intravenous Vitamin B12 Replacement in Hemodialysis Patients

NCT07781020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-24

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether intravenous (IV) vitamin B12 works better than oral vitamin B12 to correct vitamin B12 deficiency in adults on maintenance hemodialysis. The main questions it aims to answer are:

Does IV vitamin B12 raise blood B12 levels more than oral vitamin B12 over four weeks? Does IV vitamin B12 lead to more patients reaching a normal blood B12 level than oral vitamin B12? Do the two routes differ in their effect on blood counts and nerve-related symptoms such as numbness and tingling?

Participants will:

Receive either an IV injection of vitamin B12 once a week after their dialysis session, or oral vitamin B12 tablets three times a day, for four weeks Have blood tests for vitamin B12 level and blood count at the start of the study and again at week 5 Be checked for nerve-related symptoms such as numbness and tingling at the start of the study and again at week 5

Researchers will compare IV vitamin B12 to oral vitamin B12 to see which route works better at correcting B12 deficiency in hemodialysis patients.

Conditions

  • Vitamin B12 Deficiency
  • Renal Failure , Chronic
  • Renal Dialysis

Interventions

DRUG

Mecobalamin IV Injection

Mecobalamin (methylcobalamin) 1000 µg/mL ampoule, diluted in 10 mL of 0.9% sodium chloride and administered intravenously as a slow push over 3-5 minutes, once weekly for 4 weeks, via the venous port of the extracorporeal circuit at the end of the hemodialysis session. Ampoules were protected from light until administration. Distinguished from the oral intervention below by route, dose, and frequency.

DRUG

Mecobalamin Tablets

Mecobalamin (methylcobalamin) 500 µg tablet, taken orally three times daily (total 1500 µg/day) for 4 weeks. Adherence reinforced at each dialysis visit and verified by pill count. Distinguished from the intravenous intervention above by route, dose, and frequency.

Sponsors & Collaborators

  • Jinnah Hospital

    lead OTHER

Principal Investigators

  • Shafiq Cheema, MBBS, MD · Allama Iqbal Medical College/Jinnah hospital lahore

  • Mukarram Hussain · Allama Iqbal Medical College/Jinnah hospital lahore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-22
Primary Completion
2026-05-22
Completion
2026-07-15

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781020 on ClinicalTrials.gov