Vitamin Deficiencies and Suppletion in Morbid Obesity

Phase 4

Completed

• Conditions: Vitamin B12 Deficiency
• Interventions: Drug: FitForMe vitamin B12; Drug: Hydroxocobalamin

• Registration Number: NCT02270749
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FitForMe vitamin B12 tablets	FitForMe vitamin B12	25 patients receive a daily dose vitamine B12 tablets
hydroxocobalamin injection	Hydroxocobalamin	25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands