Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

Iron Deficiency Anemia Clinical Trial

Official title:

Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620137
• Other study ID #: HURJC15-15
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2015
• Last updated: November 28, 2015
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Drug:
• Multicentrum® (Pfizer, Spain) 3 months
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months
• Multicentrum® (Pfizer, Spain) 12 months
The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron serum levels	Iron serum levels will be investigated in blood samples 12 months after surgery	12 months	No
Secondary	Calcium serum levels	Calcium serum levels will be investigated in blood samples 12 months after surgery	12 months	No
Secondary	Vitamin B12 serum levels	Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery	12 months	No
Secondary	Folic acid serum levels	Vitamin B12 serum levels will be investigated in blood samples 12 months after surgery	12 months	No