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Multivitamin Support Following Bariatric Surgery

Sponsor
Bioitalia srl (Industry)
Overall Status
Completed
CT.gov ID
NCT06152965
Collaborator
(none)
20
Enrollment
1
Location
22.1
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial
    Actual Study Start Date :
    Apr 26, 2021
    Actual Primary Completion Date :
    Feb 27, 2023
    Actual Study Completion Date :
    Feb 27, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age >18yrs

    • Written Informed consent done

    • Bariatric surgery done

    Exclusion Criteria:

    • alcool or drugs abuse

    • psychiatric illness

    • allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Obesity and Lipodystrophy Center, University Hospital of Pisa Pisa Italy

    Sponsors and Collaborators

    • Bioitalia srl

    Investigators

    • Principal Investigator: Ferruccio Santini, MD, Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bioitalia srl
    ClinicalTrials.gov Identifier:
    NCT06152965
    Other Study ID Numbers:
    • GS/01/19
    First Posted:
    Dec 1, 2023
    Last Update Posted:
    Dec 1, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Bioitalia srl
    VSG
    RYGB
    micronutrients deficiency

    Study Results

    No Results Posted as of Dec 1, 2023