MedDataX Logo

Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

NCT ID: NCT02620137

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multicentrum® 3 months

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

Group Type EXPERIMENTAL

Multicentrum® (Pfizer, Spain) 3 months

Intervention Type DRUG

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

Multicentrum® 12 months

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

Group Type ACTIVE_COMPARATOR

Multicentrum® (Pfizer, Spain) 12 months

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multicentrum® (Pfizer, Spain) 3 months

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

Intervention Type DRUG

Multicentrum® (Pfizer, Spain) 12 months

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Multicentrum 3 months Multicentrum 12 months

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jaime Ruiz-Tovar, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manuel Duran

Role: STUDY_DIRECTOR

Department of Surgery

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26843085 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HURJC15-15

Identifier Type: -

Identifier Source: org_study_id