Vitamin Deficiencies and Suppletion in Morbid Obesity

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02270749
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin B12 Deficiency	Drug: Hydroxocobalamin; Drug: FitForMe vitamin B12	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vitamin Deficiencies and Suppletion in Morbid Obesity
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hydroxocobalamin injection 25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection	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.
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.

Outcome Measures

Primary Outcome Measures

1. reduction in patients with vitamin B12 deficiency [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate hospital	Arnhem		Netherlands	6800WC

Sponsors and Collaborators

• Rijnstate Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rijnstate Hospital
• ClinicalTrials.gov Identifier: NCT02270749
• Other Study ID Numbers: VITAALII
• First Posted: Oct 21, 2014
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Obesity, Morbid; Vitamin B 12 Deficiency; Avitaminosis; Vitamin B 12; Hydroxocobalamin

Study Results

No Results Posted as of Jun 11, 2020