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.
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 Type
OBSERVATIONAL
Enrollment
20
Obesity and Lipodystrophy Center, University Hospital of Pisa
Pisa, Italy
Clinical efficacy of Bariatrifast on vitamins concentration
\*25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L)
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
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
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
evaluation of body composition
\* Body weight (kilograms)
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
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