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

Completed

• Conditions: Bariatric Surgery; Obesity

• Registration Number: NCT02440087
• Lead Sponsor: Refill France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Study Start: 2015-06
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of iron deficiency	Month 1, Month 3, Month 6, Month 12 after surgery

Secondary Outcome Measures

Name	Time	Method
Measurement of Hemoglobin	Month 3, Month 6, Month 12 after surgery
Measurement of Ferritin	Month 3, Month 6, Month 12 after surgery
Measurement of Hb1Ac	Month 3, Month 6, Month 12 after surgery
Satisfaction questionnaire	Month 1, Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B6	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B1	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B12	Month 3, Month 6, Month 12 after surgery
Measurement of Albumin	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B9	Month 3, Month 6, Month 12 after surgery

Trial Locations

Locations (1)

Hopital Nord Chu42; 🇫🇷 St Priest En Jarez, France