Oral Versus Intravenous Vitamin B12 Replacement in Hemodialysis Patients

NCT07781020 | Completed DMC

• 1 other identifier: ERB165/1/30-05-2024-S1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitamin B12; Renal Failure; vitamin B12 deficiency; Administration;oral; Administration; IV

Outcome Measures

Primary Outcomes (1)

• Change in Serum Vitamin B12 Level from Baseline to Week 5

  Change in total serum vitamin B12 concentration (pg/mL) from baseline to week 5, measured by enzyme-linked immunosorbent assay. Compared between the intravenous mecobalamin group and the oral mecobalamin group using the Mann-Whitney U test.

  Baseline and Week 5 (one week after completion of the 4-week intervention)

Secondary Outcomes (6)

• Proportion of Participants Achieving Serum Vitamin B12 >200 pg/mL at Week 5

  Week 5

• Change in Hemoglobin from Baseline to Week 5

  Baseline and Week 5

• Change in Mean Corpuscular Volume from Baseline to Week 5

  Baseline and Week 5

• Change in Mean Corpuscular Hemoglobin from Baseline to Week 5

  Baseline and Week 5

• Change in Mean Corpuscular Hemoglobin Concentration from Baseline to Week 5

  Baseline and Week 5

Study Arms (2)

IV mecobalamin

ACTIVE COMPARATOR

Participants received mecobalamin 1000 µg intravenously once weekly for 4 weeks. Each dose was diluted in 10 mL of 0.9% sodium chloride and given as a slow IV push over 3-5 minutes through the venous port of the extracorporeal circuit at the end of the hemodialysis session, before rinse-back.

Drug: Mecobalamin IV Injection

Oral mecobalamin

ACTIVE COMPARATOR

Participants received mecobalamin 500 µg orally three times daily for 4 weeks. Adherence was reinforced at each dialysis visit and verified by pill count.

Drug: Mecobalamin Tablets

Interventions

Mecobalamin IV Injection DRUG

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.

Also known as: methylcobalamin, IV Mecobalamin, IV B12

IV mecobalamin

Mecobalamin Tablets DRUG

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.

Also known as: mecobalamin, Oral mecobalamin, Oral B12

Oral mecobalamin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-75 years
• Patients with diagnosed vitamin B12 deficiency (serum B12 levels \< 200 pg/mL as measured by ELISA ( Enzyme linked immunosorbent Assay)
• Patients who were on hemodialysis therapy of 4-hour duration (average 3-4 hours) thrice per week for at least the last 3 months.
• Willingness to provide informed and written consent for participation in the study

You may not qualify if:

• Patients with age \<18 years and \>75 years
• Patients with diagnosed pernicious anemia
• History of previous allergic reactions to vitamin B12 supplementation
• Patients treated with hemodialysis therapy with less than 3 months duration
• Patients on peritoneal dialysis
• Patients on strict vegetarian diets
• History of gastric or intestinal surgical procedures
• Conditions affecting the small intestine, such as ileal resection, Crohn's disease, celiac disease, or malabsorption syndrome
• Patients with known autoimmune diseases like Type 1 Diabetes Mellitus, Grave's disease, etc
• Pregnant female
• Patients who had taken metformin during the previous 3 months.
• Patients having a history of non-adherence to medications.
• Inability to comply with the study requirements due to cognitive impairment, psychiatric conditions, or any form of incapacitation.
• Participation in other clinical trials.

Sponsors & Collaborators

• Jinnah Hospital: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54550, Pakistan

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

mecobalamin; Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Shafiq Cheema, MBBS, MD

  Allama Iqbal Medical College/Jinnah hospital lahore

  STUDY DIRECTOR

• Mukarram Hussain

  Allama Iqbal Medical College/Jinnah hospital lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Model Details: Patients from successive dialysis shifts were allocated to IV or oral mecobalamin per protocol, with allocation managed to maintain comparable arm sizes.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start: February 22, 2026
• Primary Completion: May 22, 2026
• Study Completion: July 15, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)