Vitamin B12 Deficiency Clinical Trial
Official title:
Vitamin Deficiencies and Suppletion in Morbid Obesity
NCT number | NCT02270749 |
Other study ID # | VITAALII |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | June 2016 |
Verified date | June 2020 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate hospital | Arnhem |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
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 |
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