Skip to main content
OpenTrials
Completed

NCT Number: NCT02440087

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Nord Chu42

Saint-Priest-en-Jarez, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Refill Bypass

Dietary Supplement

Dietary supplement

Primary outcomes

  1. Reduction of iron deficiency

    Time frame: Month 1, Month 3, Month 6, Month 12 after surgery

Secondary outcomes

  1. Satisfaction questionnaire

    Time frame: Month 1, Month 3, Month 6, Month 12 after surgery

  2. Measurement of Ferritin

    Time frame: Month 3, Month 6, Month 12 after surgery

  3. Measurement of Vitamin B1

    Time frame: Month 3, Month 6, Month 12 after surgery

  4. Measurement of Vitamin B6

    Time frame: Month 3, Month 6, Month 12 after surgery

  5. Measurement of Vitamin B9

    Time frame: Month 3, Month 6, Month 12 after surgery

  6. Measurement of Vitamin B12

    Time frame: Month 3, Month 6, Month 12 after surgery

  7. Measurement of Hemoglobin

    Time frame: Month 3, Month 6, Month 12 after surgery

  8. Measurement of Albumin

    Time frame: Month 3, Month 6, Month 12 after surgery

  9. Measurement of Hb1Ac

    Time frame: Month 3, Month 6, Month 12 after surgery

Sponsors and collaborators

Lead sponsor

Refill France

Industry

Collaborators

  • CEISO

Registry information

Official study title

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

Acronym: Refill

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.