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Completed

NCT Number: NCT06152965

Multivitamin Support Following Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Obesity and Lipodystrophy Center, University Hospital of Pisa

Pisa, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • alcool or drugs abuse
  • psychiatric illness
  • allergy

Treatment and study plan

Primary outcomes

  1. Clinical efficacy of Bariatrifast on vitamins concentration

    Time frame: 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 outcomes

  1. evaluation of other parameters from blood test

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Bioitalia srl

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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