Clinical trial NCT06152965: Multivitamin Support Following Bariatric Surgery
Official title: Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Keywords: VSG
RYGB
micronutrients deficiency
Lead sponsor: Bioitalia srl
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* age \>18yrs
* Written Informed consent done
* Bariatric surgery done

Exclusion Criteria:

* alcool or drugs abuse
* psychiatric illness
* allergy

Primary outcomes:
measure: Clinical efficacy of Bariatrifast on vitamins concentration
timeFrame: 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:
measure: evaluation of other parameters from blood test
timeFrame: 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
measure: evaluation of body composition
timeFrame: 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
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Obesity and Lipodystrophy Center, University Hospital of Pisa
Study officials:
affiliation: Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy)
name: Ferruccio Santini, MD
role: PRINCIPAL_INVESTIGATOR
References: