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

NCT02440087 | Completed

• 1 other identifier: Refill
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Reduction of iron deficiency

  Month 1, Month 3, Month 6, Month 12 after surgery

Secondary Outcomes (9)

• Satisfaction questionnaire

  Month 1, Month 3, Month 6, Month 12 after surgery

• Measurement of Ferritin

  Month 3, Month 6, Month 12 after surgery

• Measurement of Vitamin B1

  Month 3, Month 6, Month 12 after surgery

• Measurement of Vitamin B6

  Month 3, Month 6, Month 12 after surgery

• Measurement of Vitamin B9

  Month 3, Month 6, Month 12 after surgery

Interventions

Refill Bypass DIETARY_SUPPLEMENT

Dietary supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese patients who underwent bariatric surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Refill France: lead
• CEISO: collaborator

Study Sites (1)

Hopital Nord Chu42

Saint-Priest-en-Jarez, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Radwan KASSIR, Dr.

  CHU St Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 4, 2016

Record last verified: 2016-04

Locations

FR (1)