Vitamin Deficiencies and Suppletion in Morbid Obesity
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 11, 2020
June 1, 2020
1.7 years
October 9, 2014
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
reduction in patients with vitamin B12 deficiency
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.
6 months after initiating therapy
Study Arms (2)
hydroxocobalamin injection
ACTIVE COMPARATOR25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
FitForMe vitamin B12 tablets
ACTIVE COMPARATOR25 patients receive a daily dose vitamine B12 tablets
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Vitamin B12 deficiency: \<200 pmol/l
- Vitamin B12 deficiency 6-12 months after surgery
- All patients underwent a Roux-en-Y gastric bypass
You may not qualify if:
- Creatin \>150micromol/L
- Liver enzymes \>2 times upper limit
- Other bariatric operations
- Intercurrent diseases
- Gastro-intestinal diseases
- Psychiatric disease
- Medicines which influences bone density
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate hospital
Arnhem, 6800WC, Netherlands
Related Publications (1)
Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
PMID: 29931179DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 21, 2014
Study Start
October 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 11, 2020
Record last verified: 2020-06