Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

Study Overview
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Brief Summary
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A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.

Detailed Description
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A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.

Official Title
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Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Multicentrum® (Pfizer, Spain) 3 months
* Drug: Multicentrum® (Pfizer, Spain) 12 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing laparoscopic sleeve gastrectomy BMI >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity Exclusion Criteria: documented gastroesophageal reflux patients with uncontrolled psychiatric disorders active infections or malignancies any other concomitant pathology considered as a contraindication for bariatric surgery.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicentrum® 3 months<br>Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months | Drug: Multicentrum® (Pfizer, Spain) 3 months<br>* The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months<br>* Other names: Multicentrum 3 months;|
| Active Comparator: Multicentrum® 12 months<br>Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months | Drug: Multicentrum® (Pfizer, Spain) 12 months<br>* The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months<br>* Other names: Multicentrum 12 months;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron serum levels | Iron serum levels will be investigated in blood samples 12 months after surgery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium serum levels | Calcium serum levels will be investigated in blood samples 12 months after surgery | 12 months | 
| Vitamin B12 serum levels | Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery | 12 months | 
| Folic acid serum levels | Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery | 12 months |