Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152965
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2023-11-17
Brief Title:
Multivitamin Support Following Bariatric Surgery
Sponsor:
Bioitalia srl
Organization:
Bioitalia srl
Study Overview
Official Title:
Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery a Multicenter Prospective Observational Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vitaminmineral 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 kgm2 or 35 kgm2 with at least one obesity-related comorbidity followed for one year after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None