Vitamin Deficiencies and Suppletion in Morbid Obesity
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|ClinicalTrials.gov Identifier: NCT02270749|
Recruitment Status : Unknown
Verified May 2015 by Rijnstate Hospital.
Recruitment status was: Recruiting
First Posted : October 21, 2014
Last Update Posted : May 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vitamin B12 Deficiency||Drug: Hydroxocobalamin Drug: FitForMe vitamin B12||Phase 4|
Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass.
Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin Deficiencies and Suppletion in Morbid Obesity|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: hydroxocobalamin injection
25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
patients are treated for 6 months with hydroxocobalamin. Patients will be treated with once a dose of 2000ug, after that treatment will be continued with a dose of 1000ug per 2 months. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
Active Comparator: FitForMe vitamin B12 tablets
25 patients receive a daily dose vitamine B12 tablets
Drug: FitForMe vitamin B12
patients are treated for 6 months with a daily dose of 1000ug vitamin B12 tablets. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
- reduction in patients with vitamin B12 deficiency [ Time Frame: 6 months after initiating therapy ]Before starting treatment vitamin B12, homocystein and methylmalonic acid will be measured. Two and 4 months after starting treatment vitamine B12 levels will be measured. At 6 months after initiating therapy again vitamin B12, homocystein and methylmalonic acid will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270749
|Arnhem, Netherlands, 6800WC|
|Contact: Wendy Schijns, MD 0031880057353 email@example.com|
|Principal Investigator: Frits Berends, MD PhD|
|Sub-Investigator: Wendy Schijns, MD|