ObesityRefillNCT02440087
Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery
An observational study of Obesity and Bariatric Surgery, run by Refill France at 1 site in France.
Trial summary
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Refill Bypass
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Apr 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients who underwent bariatric surgery
Who may be able to join
- Patient with a scheduled bariatric surgery "gastric bypass",
- Patient who performed a blood test before surgery,
- Patient compliant.
Who cannot join
- Allergy to components of the dietary supplement,
- Pregnancy or breastfeeding,
- Any biological abnormality considered by the investigator significant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.
This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.
Read more
Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.
The main objective is to evaluate the efficacy of the dietary supplement Refill.
The primary endpoint is the reduction of iron deficiency.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Refill Bypass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refill BypassDietary supplement
Dietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of iron deficiency
Measured: Month 1, Month 3, Month 6, Month 12 after surgery
Secondary outcomes (9)
Satisfaction questionnaire
Measured: Month 1, Month 3, Month 6, Month 12 after surgery
Measurement of Ferritin
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B1
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B6
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B9
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B12
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Hemoglobin
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Albumin
Measured: Month 3, Month 6, Month 12 after surgery
Measurement of Hb1Ac
Measured: Month 3, Month 6, Month 12 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Refill France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Radwan KASSIR, Dr., Principal investigator, CHU St Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440087
- Sponsor's protocol ID
- Refill
- Acronym
- Refill
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2015
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass
- ClinicalTrials.gov ID
- NCT02440087
- Acronym / sponsor ID
- Refill / Refill
- Conditions
- Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Refill FranceIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 May 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.
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.
This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.
Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.
The main objective is to evaluate the efficacy of the dietary supplement Refill.
The primary endpoint is the reduction of iron deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients who underwent bariatric surgery
Key inclusion criteria (3 listed)
- Patient with a scheduled bariatric surgery "gastric bypass",
- Patient who performed a blood test before surgery,
- Patient compliant.
Key exclusion criteria (3 listed)
- Allergy to components of the dietary supplement,
- Pregnancy or breastfeeding,
- Any biological abnormality considered by the investigator significant.
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 |
|---|---|---|
| Refill BypassDietary supplement | Dietary supplement | – |
Primary outcome
Reduction of iron deficiency
Time frame: Month 1, Month 3, Month 6, Month 12 after surgery
9 secondary outcomes
Satisfaction questionnaire
Time frame: Month 1, Month 3, Month 6, Month 12 after surgery
Measurement of Ferritin
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B1
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B6
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B9
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B12
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Hemoglobin
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Albumin
Time frame: Month 3, Month 6, Month 12 after surgery
Measurement of Hb1Ac
Time frame: Month 3, Month 6, Month 12 after surgery
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 4 Apr 2016.
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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.
Radwan KASSIR, Dr. principal investigator
CHU St Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Refill France at 1 site in France.
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 3 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 4 Apr 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 France. 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.
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 (time frame: Month 1, Month 3, Month 6, Month 12 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.