Vitamin B12 DeficiencyPhase 4NCT02270749
Vitamin Deficiencies and Suppletion in Morbid Obesity
A Phase 4 study testing Hydroxocobalamin and FitForMe vitamin B12 in people with Vitamin B12 Deficiency, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 months to 65 years, men only
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- Hydroxocobalamin and FitForMe vitamin B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vitamin B12 deficiency: <200 pmol/l
- Vitamin B12 deficiency 6-12 months after surgery
- All patients underwent a Roux-en-Y gastric bypass
Who cannot join
- Creatin >150micromol/L
- Liver enzymes >2 times upper limit
- Other bariatric operations
- Intercurrent diseases
- Gastro-intestinal diseases
- Psychiatric disease
- Medicines which influences bone density
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- Hydroxocobalamin, FitForMe vitamin B12
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxocobalaminDrug
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 B12Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| hydroxocobalamin injection | Active comparator | 25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection Receives: Drug: Hydroxocobalamin |
| FitForMe vitamin B12 tablets | Active comparator | 25 patients receive a daily dose vitamine B12 tablets Receives: Drug: FitForMe vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after initiating therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270749
- Sponsor's protocol ID
- VITAALII
- Status last verified
- Jun 2020
- First submitted
- 9 Oct 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
PubMed 29931179
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin Deficiencies and Suppletion in Morbid Obesity
- ClinicalTrials.gov ID
- NCT02270749
- Acronym / sponsor ID
- VITAALII
- Conditions
- Vitamin B12 Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroxocobalamin injection | Active comparator | Drug: Hydroxocobalamin25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection |
| FitForMe vitamin B12 tablets | Active comparator | Drug: FitForMe vitamin B1225 patients receive a daily dose vitamine B12 tablets |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Vitamin B12 deficiency: <200 pmol/l
- Vitamin B12 deficiency 6-12 months after surgery
- All patients underwent a Roux-en-Y gastric bypass
Key exclusion criteria (8 listed)
- Creatin >150micromol/L
- Liver enzymes >2 times upper limit
- Other bariatric operations
- Intercurrent diseases
- Gastro-intestinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxocobalaminpatients 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. | Drug | hydroxocobalamin injection |
| FitForMe vitamin B12patients 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. | Drug | FitForMe vitamin B12 tablets |
Primary outcome
reduction in patients with vitamin B12 deficiency
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 29931179Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxocobalamin and FitForMe vitamin B12 in people with Vitamin B12 Deficiency, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in patients with vitamin B12 deficiency (time frame: 6 months after initiating therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.