Vitamin deficiencies and supplement in overweight patients
- Conditions
- Vitamin B12 deficienciesTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-004835-60-NL
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients who underwent RYGB
Patients who developed a vitamin B12 deficiency postoperatively
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Creatinine> 150 micromol / L
Liver enzymes> 2 times the upper limit
Previous operations on the gastrointestinal tract (except RYGB)
Intercurrerende disease
Gastrointestinal disease
psychiatric illness
known pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Prospective evaluation of the effect of Vitamin B12 tablets (which are available in stores) in comparison with hydroxocobalamine injections for vitamin B12 deficiencies in patients who underwent a Roux-en-Y Gastric Bypass.;Secondary Objective: Not applicable;Primary end point(s): Vitamin B12 deficiencies after 1 year;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months after starting of therapy
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none