Clinical trial NCT02440087: Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery
Official title: Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Lead sponsor: Refill France
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2015-05-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients who underwent bariatric surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of iron deficiency
timeFrame: Month 1, Month 3, Month 6, Month 12 after surgery
Secondary outcomes:
measure: Satisfaction questionnaire
timeFrame: Month 1, Month 3, Month 6, Month 12 after surgery
measure: Measurement of Ferritin
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Vitamin B1
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Vitamin B6
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Vitamin B9
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Vitamin B12
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Hemoglobin
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Albumin
timeFrame: Month 3, Month 6, Month 12 after surgery
measure: Measurement of Hb1Ac
timeFrame: Month 3, Month 6, Month 12 after surgery
Other outcomes:
Locations:
city: St Priest En Jarez
country: France
facility: Hopital Nord Chu42
Study officials:
affiliation: CHU St Etienne
name: Radwan KASSIR, Dr.
role: PRINCIPAL_INVESTIGATOR
References: