A prospective comparison of vitamin B12 supplementation after gastric bypass surgery( sublingual vs. intramuscular)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014468-20-AT

Enrollment

Unknown

Registered

2010-02-22

Start date

2010-03-22

Completion date

Unknown

Last updated

2016-11-21

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: HEPAVIT 2500 µg - Ampullen Product Name: HEPAVIT 2500 µg - Ampullen Pharmaceutical Form: Injection* Trade Name: Spray vitamin B12 ( Additional Nutritian ) Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 19-70 BMI_>40 consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Additional Nutritianl substitution of vitamin B12 in the previous 3 months - Mycardioal infarction within the previos 6 months - malignant disease - kidney disorder (creatinine > 1.3 mg/dl) - liver parameters > ULN - Adipositas because of endocrine disoerder (M. Cushing, Prader-Willi, Laurence-Moon-Biedl-Syndrom) - anamnestic stroke - psychiatric disorder - pregnancy - breast feeding - Drug or alcohol abuse - treatment for reduction of apetite (Sibutiramine, Fenfluramine, Phentermine, Dexfenfluramine) - Antidepressants - Antipsychotics - Amphetamines - Systemic corticosteroids - other multivitamine tretament

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of two substitution methods (intramuscular vs. sublingual) for vitamin B12 deficiency.;Secondary Objective: ;Primary end point(s): Holotranscobalamin and Vit.B12 levels in plasma	—

Countries

Austria

Outcome results

None listed

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