ObesityPhase 4NCT01609387
Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
A Phase 4 study testing Fit For me and Davitamon in people with Obesity and Vitamin Deficiency, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
This study is a double blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Vitamin Deficiency
- What is being tested?
- Fit For me and Davitamon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Dec 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients on the waiting list for RYGB or gastric band and meets
- Age between 18-65 years
Who cannot join
- Creatinine > 150micromol / L
- Liver enzymes > 2 times the upper limit
- Previous surgery on the gastrointestinal tract
- Intercurrerence disease
- Gastrointestinal Diseases
- Psychiatric illness
- Drugs that affect bone metabolism
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Vitamin Supplementation in Morbidly Obese Patient
This study is a double blind randomized controlled trial.
Read the detailed description
Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.
- Conditions
- Obesity, Vitamin Deficiency
- Being tested
- Fit For me, Davitamon
- Keywords
- Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients
- Medical subject headings
- Obesity, Avitaminosis, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit For meDietary supplement
DavitamonDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Gastric Banding new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) Receives: Dietary Supplement: Fit For me |
| Gastric Banding current vitamins | Active comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) Receives: Dietary Supplement: Davitamon |
| RYGB new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients Receives: Dietary Supplement: Fit For me |
| RYGB current vitamins | Active comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients) Receives: Dietary Supplement: Davitamon |
| Gastric sleeve new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) Receives: Dietary Supplement: Fit For me |
| Gastric sleeve current vitamins | Active comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) Receives: Dietary Supplement: Davitamon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of iron deficiency in obese patients
Measured: one year
Secondary outcomes (1)
Reduction of vitamin D and vitamin B12 deficiency
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2015
- Study completionDec 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 ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Homan, Rijnstate Hospital
- Investigators
- Frits Berends, MD,PhD, Principal investigator, Rijnstate Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609387
- Sponsor's protocol ID
- LTC 745
- Status last verified
- May 2016
- First submitted
- 15 Sep 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Heusschen L, Schijns W, Ploeger N, Deden LN, Hazebroek EJ, Berends FJ, Aarts EO. The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT. Obes Surg. 2020 Apr;30(4):1280-1290. doi: 10.1007/s11695-019-04252-1.
PubMed 31776782
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Vitamin Supplementation in Morbidly Obese Patient
- ClinicalTrials.gov ID
- NCT01609387
- Acronym / sponsor ID
- LTC 745
- Conditions
- Obesity, Vitamin Deficiency
- Keywords
- Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jun 2012 (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.
This study is a double blind randomized controlled trial.
Detailed description
Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Gastric Banding new vitamins | Experimental | Dietary Supplement: Fit For meRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) |
| Gastric Banding current vitamins | Active comparator | Dietary Supplement: DavitamonRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) |
| RYGB new vitamins | Experimental | Dietary Supplement: Fit For meRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients |
| RYGB current vitamins | Active comparator | Dietary Supplement: DavitamonRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients) |
| Gastric sleeve new vitamins | Experimental | Dietary Supplement: Fit For meRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) |
| Gastric sleeve current vitamins | Active comparator | Dietary Supplement: DavitamonRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients on the waiting list for RYGB or gastric band and meets
- Age between 18-65 years
Key exclusion criteria (8 listed)
- Creatinine > 150micromol / L
- Liver enzymes > 2 times the upper limit
- Previous surgery on the gastrointestinal tract
- Intercurrerence disease
- Gastrointestinal 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 |
|---|---|---|
| Fit For me | Dietary supplement | Gastric Banding new vitamins, Gastric sleeve new vitamins, RYGB new vitamins |
| Davitamon | Dietary supplement | Gastric Banding current vitamins, Gastric sleeve current vitamins, RYGB current vitamins |
Primary outcome
Reduction of iron deficiency in obese patients
Time frame: one year
1 secondary outcome
Reduction of vitamin D and vitamin B12 deficiency
Time frame: one year
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 3 May 2016.
- Derived from this study: PubMed 31776782Heusschen L, Schijns W, Ploeger N, Deden LN, Hazebroek EJ, Berends FJ, Aarts EO. The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT. Obes Surg. 2020 Apr;30(4):1280-1290. doi: 10.1007/s11695-019-04252-1.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Frits Berends, MD,PhD principal investigator
Rijnstate Arnhem
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 Fit For me and Davitamon in people with Obesity and Vitamin 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 2 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 3 May 2016. 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 of iron deficiency in obese patients (time frame: one year). 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 NCT01609387, 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 3 May 2016.