Multivitamin Support Following Bariatric Surgery

Completed

• Conditions: Bariatric Surgery

• Registration Number: NCT06152965
• Lead Sponsor: Bioitalia srl

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.

Study Timeline

• Study Start: 2021-04-26
• Primary Completion: 2023-02-27
• Study Completion: 2023-02-27
• Status Verified: 2023-11
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age >18yrs
• Written Informed consent done
• Bariatric surgery done

Exclusion Criteria

• alcool or drugs abuse
• psychiatric illness
• allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical efficacy of Bariatrifast on vitamins concentration	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)

Secondary Outcome Measures

Name	Time	Method
evaluation of other parameters from blood test	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	* 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
evaluation of body composition	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	\* Body weight (kilograms)

Trial Locations

Locations (1)

Obesity and Lipodystrophy Center, University Hospital of Pisa; 🇮🇹 Pisa, Italy