A prospective comparison of vitamin B12 supplementation after gastric bypass surgery( sublingual vs. intramuscular)
- Conditions
- Vitamin B12 deficiency
- Registration Number
- EUCTR2009-014468-20-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik für Chirurgie, Abt.für Allgemeinchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method