Multivitamin Support Following Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06152965
• Other study ID #: GS/01/19
• Status: Completed
• Start date: April 26, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: November 2023
• Source: Bioitalia srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 micronutrient deficiencies in patients submitted to BS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age >18yrs

• Written Informed consent done

• Bariatric surgery done

Exclusion Criteria:

• alcool or drugs abuse

• psychiatric illness

• allergy

Related Conditions & MeSH terms

• Bariatric Surgery

Locations

Country	Name	City	State
Italy	Obesity and Lipodystrophy Center, University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Bioitalia srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy of Bariatrifast on vitamins concentration	*25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L)	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	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	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	evaluation of body composition	* Body weight (kilograms)	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