NCT07029698

A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth

Efficacy and Safety of a Parenterally Administered Fixed Vitamin Combination (Vitamin B6, B12 and Folic Acid) On Vitamin B12 Status and Methylation Capacity in Cobalamin Deficiency Compared to Oral Vitamin B12 Supplementation

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary efficacy objective: To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment. Secondary efficacy objectives: To evaluate the effects of a parenterally vitamin B12 combination versus an oral vitamin B12 mono therapy after 4 weeks of treatment on: * Serum holotranscobalamin * Serum homocysteine * Serum methylmalonic acid * Combined vitamin B12 markers (cB12) * Serum folic acid * Serum vitamin B6 * Serum S-adenosylmethione (SAM) * Serum S-adenosylhomocysteine (SAH) * SAM/SAH ratio * WHO-5 Well-Being Index * Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) * Visual analogue scale (VAS) EQ-5D. Safety objectives: To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.

Conditions

• Vitamin B12 Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin B12, Vitamin B6, Folic acid	A solution for intramuscular injection of fixed vitamin combination (5 mg vitamin B6, 1 mg B12 and 1,05 mg folic acid )
DRUG	Vitamin B12 (Cyanocobalamin)	oral tablets of 1mg Vitamin B12

Timeline

• Start date: 2025-04-16
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

2 sites across 1 country: Ukraine