Multivitamin Support Following Bariatric Surgery

NCT06152965 | Completed DMC

• 1 other identifier: GS/01/19
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery

Keywords

VSG; RYGB; micronutrients deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This observational, prospective study 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. In the, 10 patients had hypertension, 5 insulin resistance, 5 type 2 diabetes, 2 non-alcoholic liver disease, 7 gastroesophageal reflux disease, 7 dyslipidemia and 2 obstructive sleep apnea. Ten of them underwent VSG and the other 10 RYGB. Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa

You may qualify if:

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

You may not qualify if:

• alcool or drugs abuse
• psychiatric illness
• allergy

Sponsors & Collaborators

• Bioitalia srl: lead

Study Sites (1)

Obesity and Lipodystrophy Center, University Hospital of Pisa

Pisa, Italy

Location

Related Publications (1)

• 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.

  PMID: 38714632 DERIVED

Study Officials

• Ferruccio Santini, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 1, 2023
• Study Start: April 26, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)