Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery (Refill)

April 1, 2016 updated by: Refill France

Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass

This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.

This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.

Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.

The main objective is to evaluate the efficacy of the dietary supplement Refill.

The primary endpoint is the reduction of iron deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • St Priest En Jarez, France
        • Hopital Nord Chu42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Obese patients who underwent bariatric surgery

Description

Inclusion Criteria:

  • Patient with a scheduled bariatric surgery "gastric bypass",
  • Patient who performed a blood test before surgery,
  • Patient compliant.

Exclusion Criteria:

  • Allergy to components of the dietary supplement,
  • Pregnancy or breastfeeding,
  • Any biological abnormality considered by the investigator significant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of iron deficiency
Time Frame: Month 1, Month 3, Month 6, Month 12 after surgery
Month 1, Month 3, Month 6, Month 12 after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction questionnaire
Time Frame: Month 1, Month 3, Month 6, Month 12 after surgery
Month 1, Month 3, Month 6, Month 12 after surgery
Measurement of Ferritin
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B1
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B6
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B9
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B12
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Hemoglobin
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Albumin
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery
Measurement of Hb1Ac
Time Frame: Month 3, Month 6, Month 12 after surgery
Month 3, Month 6, Month 12 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Refill France

Collaborators

CEISO

Investigators

  • Principal Investigator: Radwan KASSIR, Dr., CHU St Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Refill

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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