Vitamin Deficiencies and Suppletion in Morbid Obesity

Vitamin B12 Deficiency Clinical Trial

Official title:

Vitamin Deficiencies and Suppletion in Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270749
• Other study ID #: VITAALII
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Obesity, Morbid
• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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