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

Obesity Clinical Trial

— Refill  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440087
• Other study ID #: Refill
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: April 1, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Refill France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery
• Malnutrition
• Obesity

Intervention

Dietary Supplement:
• Refill Bypass
Dietary supplement

Locations

Country	Name	City	State
France	Hopital Nord Chu42	St Priest En Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Refill France	CEISO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of iron deficiency		Month 1, Month 3, Month 6, Month 12 after surgery	No
Secondary	Satisfaction questionnaire		Month 1, Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Ferritin		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Vitamin B1		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Vitamin B6		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Vitamin B9		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Vitamin B12		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Hemoglobin		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Albumin		Month 3, Month 6, Month 12 after surgery	No
Secondary	Measurement of Hb1Ac		Month 3, Month 6, Month 12 after surgery	No