Vitamin Deficiencies and Suppletion in Morbid Obesity

Vitamin Deficiencies and Suppletion in Morbid Obesity

Sponsors

Lead Sponsor: Rijnstate Hospital

Source Rijnstate Hospital
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.

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.

Overall Status Completed
Start Date 2014-10-01
Completion Date 2016-06-01
Primary Completion Date 2016-06-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
reduction in patients with vitamin B12 deficiency 6 months after initiating therapy
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hydroxocobalamin

Description: 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.

Arm Group Label: hydroxocobalamin injection

Intervention Type: Drug

Intervention Name: FitForMe vitamin B12

Description: 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.

Arm Group Label: FitForMe vitamin B12 tablets

Eligibility

Criteria:

Inclusion Criteria: - Vitamin B12 deficiency: <200 pmol/l - Vitamin B12 deficiency 6-12 months after surgery - All patients underwent a Roux-en-Y gastric bypass Exclusion Criteria: 1. Creatin >150micromol/L 2. Liver enzymes >2 times upper limit 3. Other bariatric operations 4. Intercurrent diseases 5. Gastro-intestinal diseases 6. Psychiatric disease 7. Medicines which influences bone density 8. Pregnancy

Gender:

Male

Minimum Age:

18 Months

Maximum Age:

65 Years

Healthy Volunteers:

No

Location
Facility: Rijnstate hospital
Location Countries

Netherlands

Verification Date

2020-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: hydroxocobalamin injection

Type: Active Comparator

Description: 25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection

Label: FitForMe vitamin B12 tablets

Type: Active Comparator

Description: 25 patients receive a daily dose vitamine B12 tablets

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News