Vitamin Deficiencies and Suppletion in Morbid Obesity

Rijnstate Hospital

Status and phase: Completed; Phase 4

Conditions: Vitamin B12 Deficiency

Treatments: Drug: Hydroxocobalamin; Drug: FitForMe vitamin B12

Study type: Interventional

Funder types: Other

Identifiers

NCT02270749

VITAALII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 18 months to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

hydroxocobalamin injection

Active Comparator group

Description:

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

Treatment:

Drug: Hydroxocobalamin

FitForMe vitamin B12 tablets

Active Comparator group

Description:

25 patients receive a daily dose vitamine B12 tablets

Treatment:

Drug: FitForMe vitamin B12