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OpenTrials
Completed

NCT Number: NCT02620137

Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multicentrum® (Pfizer, Spain) 3 months

Drug

The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months

Other names: Multicentrum 3 months

Multicentrum® (Pfizer, Spain) 12 months

Drug

The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months

Other names: Multicentrum 12 months

Primary outcomes

  1. Iron serum levels

    Time frame: 12 months

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

Secondary outcomes

  1. Calcium serum levels

    Time frame: 12 months

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

  2. Vitamin B12 serum levels

    Time frame: 12 months

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

  3. Folic acid serum levels

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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