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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02440087

Acronym

Refill

Enrollment

Registered

2015-05-12

Start date

2015-06-30

Completion date

2016-04-30

Last updated

2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity

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.

Interventions

DIETARY_SUPPLEMENTRefill Bypass

Dietary supplement

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reduction of iron deficiency	Month 1, Month 3, Month 6, Month 12 after surgery

Secondary

Measure	Time frame
Measurement of Vitamin B6	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B9	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B12	Month 3, Month 6, Month 12 after surgery
Measurement of Hemoglobin	Month 3, Month 6, Month 12 after surgery
Measurement of Vitamin B1	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 Ferritin	Month 3, Month 6, Month 12 after surgery
Measurement of Albumin	Month 3, Month 6, Month 12 after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026