Comparison of the efficacy and tolerability of a vitamin administration as a syringe with an intake as a tablet

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 - EASYVit

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003619-23-DE

Enrollment

Registered

2019-10-08

Start date

2019-11-29

Completion date

Unknown

Last updated

2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitamin B12 deficiency

Interventions

Trade Name: Medivitan® iV Fertigspritze 5 mg, 1 mg 1,05 mg, Injektionslösung Product Name: Medivitan iV Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Provision of written informed consent to participate in the study (according to AMG §40 (1)3b). Female and male patients aged =18. Diagnosis of vitamin B12 deficiency, defined as serum vitamin B12 =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Active or recent vitamin B12 intake (the subject must not receive vitamin B12 drugs or food supplements for at least 6 months). Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening. Any contraindication to one of the study drugs. Pregnant or nursing (lactating) women. Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. Subjects with anemia (haemoglobin < 10 mg/dL) or neurological symptoms due to vitamin B12 deficiency. Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection) Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1. Cognitive or behavioral abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures. Inability to take oral medication

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 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. Adverse events (AEs) Serious adverse events (SAEs) and suspected unexpected serious adverse drug reactions (SUSARs) Vital signs (body weight, blood pressure and pulse rate) Clinical laboratory tests;Timepoint(s) of evaluation of this end point: changes from baseline to week 4	—

Measure

Time frame

Secondary end point(s): 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. Adverse events (AEs) Serious adverse events (SAEs) and suspected unexpected serious adverse drug reactions (SUSARs) Vital signs (body weight, blood pressure and pulse rate) Clinical laboratory tests;Timepoint(s) of evaluation of this end point: changes from baseline to week 4

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Primary

Measure	Time frame
Main 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 Objective: 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.;Primary end point(s): serum vitamin B12 concentration (pmol/L).;Timepoint(s) of evaluation of this end point: change from baseline to week 4 (28 days) in	—

Measure

Time frame

Main 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 Objective: 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.;Primary end point(s): serum vitamin B12 concentration (pmol/L).;Timepoint(s) of evaluation of this end point: change from baseline to week 4 (28 days) in

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Countries

Germany

Contacts

Public ContactFachgebiet Klinische Prüfung

Bundesinstitut für Arzneimittel und Medizinprodukte

klinpruefung@bfarm.de+492282074318

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026