NCT02270749

Vitamin Deficiencies and Suppletion in Morbid Obesity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: Male
• Age: 18 Months – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Vitamin B12 Deficiency

Interventions

Type	Name	Description
DRUG	Hydroxocobalamin	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.
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-10-21
• Last updated: 2020-06-11

Locations

1 site across 1 country: Netherlands