Bariatric SurgeryNCT06152965
Multivitamin Support Following Bariatric Surgery
An observational study of Bariatric Surgery, run by Bioitalia srl at 1 site in Italy.
Trial summary
Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2021to 27 Feb 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational, prospective study included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity. In the, 10 patients had hypertension, 5 insulin resistance, 5 type 2 diabetes, 2 non-alcoholic liver disease, 7 gastroesophageal reflux disease, 7 dyslipidemia and 2 obstructive sleep apnea. Ten of them underwent VSG and the other 10 RYGB. Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa
Who may be able to join
- age >18yrs
- Written Informed consent done
- Bariatric surgery done
Who cannot join
- alcool or drugs abuse
- psychiatric illness
- allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial
Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted to BS.
Read the detailed description
Although BS effectively reduces body weight, improves metabolic alterations, and enhances overall health, it may also lead to micronutrients deficiency. This prospective observational study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity, followed for one year after surgery.
- Conditions
- Bariatric Surgery
- Keywords
- VSG, RYGB, micronutrients deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of Bariatrifast on vitamins concentration
*25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L)
Measured: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
Secondary outcomes (2)
evaluation of other parameters from blood test
- Blood counts: red blood cells in number per microliter (10^6/microliter); hemoglobin in gram/liter (g/L); white blood cells in number per microliter (10^3/microliter); platelets in number per microliter (10^3/microliter)
- ferritin in microgram/Liter (mcg/L),
- ionized calcium in millimoles per liter (mmol/L),
- PTH parathormone in nanogram/Liter (ng/L),
- folic acid microgram/Liter (mcg/L), recorded at each visit
Measured: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
evaluation of body composition
- Body weight (kilograms)
Measured: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start26 Apr 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
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 Bariatric SurgeryStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioitalia srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferruccio Santini, MD, Principal investigator, Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152965
- Sponsor's protocol ID
- GS/01/19
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Basolo A, Bechi Genzano S, Vitti J, Salvetti G, Gilio D, Ceccarini G, Scartabelli G, Lippi C, Bellini R, Mancini R, D'Imporzano S, Moretto C, Angeli V, Troiani D, Fierabracci P, Jaccheri R, Calderone A, Poma AM, Chiovato L, Saponati G, Santini F. Efficacy of multivitamin support following bariatric surgery in patients with obesity: a prospective observational study. Eat Weight Disord. 2024 May 7;29(1):34. doi: 10.1007/s40519-024-01655-7.
PubMed 38714632
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT06152965
- Acronym / sponsor ID
- GS/01/19
- Conditions
- Bariatric Surgery
- Keywords
- VSG, RYGB, micronutrients deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bioitalia srlIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 1 Dec 2023 (actual)
- 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.
Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted to BS.
Detailed description
Although BS effectively reduces body weight, improves metabolic alterations, and enhances overall health, it may also lead to micronutrients deficiency. This prospective observational study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity, followed for one year after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational, prospective study included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity. In the, 10 patients had hypertension, 5 insulin resistance, 5 type 2 diabetes, 2 non-alcoholic liver disease, 7 gastroesophageal reflux disease, 7 dyslipidemia and 2 obstructive sleep apnea. Ten of them underwent VSG and the other 10 RYGB. Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa
Key inclusion criteria (3 listed)
- age >18yrs
- Written Informed consent done
- Bariatric surgery done
Key exclusion criteria (3 listed)
- alcool or drugs abuse
- psychiatric illness
- allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical efficacy of Bariatrifast on vitamins concentration
Time frame: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
*25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L)
2 secondary outcomes
evaluation of other parameters from blood test
Time frame: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
evaluation of body composition
Time frame: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS
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 1 Dec 2023.
- Derived from this study: PubMed 38714632Basolo A, Bechi Genzano S, Vitti J, Salvetti G, Gilio D, Ceccarini G, Scartabelli G, Lippi C, Bellini R, Mancini R, D'Imporzano S, Moretto C, Angeli V, Troiani D, Fierabracci P, Jaccheri R, Calderone A, Poma AM, Chiovato L, Saponati G, Santini F. Efficacy of multivitamin support following bariatric surgery in patients with obesity: a prospective observational study. Eat Weight Disord. 2024 May 7;29(1):34. doi: 10.1007/s40519-024-01655-7.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Recruiting
HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
RecruitingObservational study
15-years Outcomes of Sleeve Gastrectomy on Weight Loss
Bariatric Surgery, Sleeve Gastrectomy
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.
Ferruccio Santini, MD principal investigator
Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy)
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 Bariatric Surgery, run by Bioitalia srl at 1 site in Italy.
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 1 Dec 2023. 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 Italy. 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?
Clinical efficacy of Bariatrifast on vitamins concentration (time frame: One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS). 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 NCT06152965, 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 1 Dec 2023.