Procedure-specific bariatric supplements to protect micronutrient balance after weight-loss surgery
A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery
This study will test whether tailored Elan bariatric supplements with a low, consistent vitamin B6 dose help prevent vitamin B6 excess and keep other nutrients balanced in adults having sleeve gastrectomy, Roux-en-Y, or one-anastomosis gastric bypass.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 249 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Egypt) |
| Trial ID | NCT07021248 on ClinicalTrials.gov |
What this trial studies
This randomized, phase 4 trial gives adults undergoing primary sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass one of three Elan procedure-specific supplements (Believe, Compass, or Supreme) that all contain a standardized 400 µg/day vitamin B6 dose. Participants are followed for 12 months with measurements of vitamin B6 levels, other micronutrients, anthropometry, and supplement adherence. The trial compares rates of B6 hypervitaminosis and deficiency across surgical types while monitoring broader nutritional status. Results are intended to guide safer, procedure-matched supplementation after metabolic and bariatric surgery.
Who should consider this trial
Good fit: Adults aged 18–65 undergoing a primary sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass who meet IFSO surgical criteria, can consent, and can attend scheduled follow-up visits for 12 months are eligible.
Not a fit: Patients having revision or secondary bariatric procedures, those with known B6 hypersensitivity, or those unable to adhere to the 12-month follow-up schedule are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, procedure-specific supplements with a conservative B6 dose could lower the risk of vitamin B6 toxicity and improve long-term micronutrient health after bariatric surgery.
How similar studies have performed: This approach is novel for comparing standardized, procedure-specific low B6 supplementation across surgical types, and no prior prospective randomized trials have directly tested its effect on post-bariatric B6 hypervitaminosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible participants will be adults: * Aged 18 to 65 years * Undergoing primary metabolic and bariatric surgery (MBS), including sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB). * Patients must meet established surgical indications as defined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), specifically: a body mass index (BMI) greater than 30 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea) * or a BMI greater than 35 kg/m² irrespective of comorbidities. * Eligible participants must be capable of providing informed consent, willing to adhere to the prescribed supplement regimen, and able to complete scheduled postoperative follow-up visits for 12 months. Exclusion Criteria: Exclusion criteria include: * Revision or secondary MBS procedures * Known hypersensitivity to vitamin B6 or any component of the supplement formulations * Pregnancy or planned pregnancy during the study period * Any pre-existing medical condition known to interfere with vitamin B6 metabolism. This includes, but is not limited to, severe hepatic or renal dysfunction, peripheral neuropathy, and the use of medications such as isoniazid, phenytoin, or levodopa. Additional exclusions include chronic gastrointestinal conditions affecting absorption (e.g., inflammatory bowel disease, celiac disease), porphyria, or any other clinical scenario that, in the judgment of the investigators, may compromise compliance or the reliability of follow-up. * Patients who are already receiving high-dose vitamin B6 supplementation or have abnormal preoperative B6 levels will be excluded.
Where this trial is running
Alexandria, Egypt
- The surgical department of Medical Research Institute Hospital, Alexandria University — Alexandria, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Ashour, Ph.D. (Professor)
- Email: mohamed.ashour@alexu.edu.eg
- Phone: +201002600970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.