Multivitamin Support Following Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-26

Study Completion Date

2023-02-27

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery

Keywords

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VSG RYGB micronutrients deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \>18yrs
* Written Informed consent done
* Bariatric surgery done

Exclusion Criteria

* alcool or drugs abuse
* psychiatric illness
* allergy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ferruccio Santini, MD

Role: PRINCIPAL_INVESTIGATOR

Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy)

Locations

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Obesity and Lipodystrophy Center, University Hospital of Pisa

Pisa, , Italy

Site Status

Countries

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Italy

References

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Basolo A, Bechi Genzano S, Vitti J, Salvetti G, Gilio D, Ceccarini G, Scartabelli G, Lippi C, Bellini R, Mancini R, D'Imporzano S, Moretto C, Angeli V, Troiani D, Fierabracci P, Jaccheri R, Calderone A, Poma AM, Chiovato L, Saponati G, Santini F. Efficacy of multivitamin support following bariatric surgery in patients with obesity: a prospective observational study. Eat Weight Disord. 2024 May 7;29(1):34. doi: 10.1007/s40519-024-01655-7.

Reference Type DERIVED

PMID: 38714632 (View on PubMed)

Other Identifiers

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GS/01/19

Identifier Type: -

Identifier Source: org_study_id