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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

NCT07029698 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-06-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medice Arzneimittel Pütter GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Ukraine

Study Locations

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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 NCT07029698 on ClinicalTrials.gov