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Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Multicentrum® (Pfizer, Spain) 3 months
Multicentrum® (Pfizer, Spain) 12 months
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency Anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multicentrum® 3 months

    Multicentrum® 12 months

    Arm Description

    Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months

    Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months

    Outcomes

    Primary Outcome Measures

    Iron serum levels
    Iron serum levels will be investigated in blood samples 12 months after surgery

    Secondary Outcome Measures

    Calcium serum levels
    Calcium serum levels will be investigated in blood samples 12 months after surgery
    Vitamin B12 serum levels
    Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery
    Folic acid serum levels
    Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery

    Full Information

    First Posted
    November 26, 2015
    Last Updated
    November 28, 2015
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02620137
    Brief Title
    Maintenance of Multivitamin Supplements After Sleeve Gastrectomy
    Official Title
    Maintenance of Multivitamin Supplements After Sleeve Gastrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multicentrum® 3 months
    Arm Type
    Experimental
    Arm Description
    Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months
    Arm Title
    Multicentrum® 12 months
    Arm Type
    Active Comparator
    Arm Description
    Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Multicentrum® (Pfizer, Spain) 3 months
    Other Intervention Name(s)
    Multicentrum 3 months
    Intervention Description
    The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Multicentrum® (Pfizer, Spain) 12 months
    Other Intervention Name(s)
    Multicentrum 12 months
    Intervention Description
    The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months
    Primary Outcome Measure Information:
    Title
    Iron serum levels
    Description
    Iron serum levels will be investigated in blood samples 12 months after surgery
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Calcium serum levels
    Description
    Calcium serum levels will be investigated in blood samples 12 months after surgery
    Time Frame
    12 months
    Title
    Vitamin B12 serum levels
    Description
    Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery
    Time Frame
    12 months
    Title
    Folic acid serum levels
    Description
    Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Duran
    Organizational Affiliation
    Department of Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26843085
    Citation
    Ruiz-Tovar J, Llavero C, Zubiaga L, Boix E; OBELCHE group. Maintenance of Multivitamin Supplements After Sleeve Gastrectomy. Obes Surg. 2016 Oct;26(10):2324-30. doi: 10.1007/s11695-016-2084-5.
    Results Reference
    derived

    Learn more about this trial

    Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

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