Iron Deficiency AnemiaPhase 3NCT02620137
Maintenance of Multivitamin Supplements After Sleeve Gastrectomy
A Phase 3 study testing Multicentrum® (Pfizer, Spain) 3 months and Multicentrum® (Pfizer, Spain) 12 months in people with Iron Deficiency Anemia, run by Hospital General Universitario Elche.
Trial summary
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Multicentrum® (Pfizer, Spain) 3 months and Multicentrum® (Pfizer, Spain) 12 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Nov 2015
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing laparoscopic sleeve gastrectomy
- BMI >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
Who cannot join
- documented gastroesophageal reflux
- patients with uncontrolled psychiatric disorders
- active infections or malignancies
- any other concomitant pathology considered as a contraindication for bariatric surgery.
About this study
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.
Read the detailed description
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Multicentrum® (Pfizer, Spain) 3 months, Multicentrum® (Pfizer, Spain) 12 months
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicentrum® (Pfizer, Spain) 3 monthsDrug
Also called Multicentrum 3 months
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months
Multicentrum® (Pfizer, Spain) 12 monthsDrug
Also called Multicentrum 12 months
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Multicentrum® 3 months | Experimental | Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months Receives: Drug: Multicentrum® (Pfizer, Spain) 3 months |
| Multicentrum® 12 months | Active comparator | Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months Receives: Drug: Multicentrum® (Pfizer, Spain) 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron serum levels
Iron serum levels will be investigated in blood samples 12 months after surgery
Measured: 12 months
Secondary outcomes (3)
Calcium serum levels
Calcium serum levels will be investigated in blood samples 12 months after surgery
Measured: 12 months
Vitamin B12 serum levels
Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery
Measured: 12 months
Folic acid serum levels
Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
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 Iron Deficiency AnemiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Manuel Duran, Study director, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620137
- Sponsor's protocol ID
- HURJC15-15
- Status last verified
- Nov 2015
- First submitted
- 26 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruiz-Tovar J, Llavero C, Zubiaga L, Boix E; OBELCHE group. Maintenance of Multivitamin Supplements After Sleeve Gastrectomy. Obes Surg. 2016 Oct;26(10):2324-30. doi: 10.1007/s11695-016-2084-5.
PubMed 26843085
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Multivitamin Supplements After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02620137
- Acronym / sponsor ID
- HURJC15-15
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Dec 2015 (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.
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.
Detailed description
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicentrum® 3 months | Experimental | Drug: Multicentrum® (Pfizer, Spain) 3 monthsPatients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months |
| Multicentrum® 12 months | Active comparator | Drug: Multicentrum® (Pfizer, Spain) 12 monthsPatients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing laparoscopic sleeve gastrectomy
- BMI >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
Key exclusion criteria (4 listed)
- documented gastroesophageal reflux
- patients with uncontrolled psychiatric disorders
- active infections or malignancies
- any other concomitant pathology considered as a contraindication for bariatric surgery.
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 |
|---|---|---|
| Multicentrum® (Pfizer, Spain) 3 monthsAlso: Multicentrum 3 monthsThe multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months | Drug | Multicentrum® 3 months |
| Multicentrum® (Pfizer, Spain) 12 monthsAlso: Multicentrum 12 monthsThe multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months | Drug | Multicentrum® 12 months |
Primary outcome
Iron serum levels
Time frame: 12 months
Iron serum levels will be investigated in blood samples 12 months after surgery
3 secondary outcomes
Calcium serum levels
Time frame: 12 months
Vitamin B12 serum levels
Time frame: 12 months
Folic acid serum levels
Time frame: 12 months
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 2 Dec 2015.
- Derived from this study: PubMed 26843085Ruiz-Tovar J, Llavero C, Zubiaga L, Boix E; OBELCHE group. Maintenance of Multivitamin Supplements After Sleeve Gastrectomy. Obes Surg. 2016 Oct;26(10):2324-30. doi: 10.1007/s11695-016-2084-5.
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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.
Manuel Duran study director
Department of Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multicentrum® (Pfizer, Spain) 3 months and Multicentrum® (Pfizer, Spain) 12 months in people with Iron Deficiency Anemia, run by Hospital General Universitario Elche.
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 4 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Iron serum levels (time frame: 12 months). 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 NCT02620137, 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 2 Dec 2015.