Elan bariatric supplements versus standard multivitamins after weight-loss surgery.
A Double-Blinded Randomized Controlled Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, and One-Anastomosis Gastric Bypass
This will test whether Elan's surgery-specific vitamin supplements work better than standard multivitamins for adults having sleeve gastrectomy, Roux-en-Y, or one-anastomosis gastric bypass.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 624 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT07021170 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for primary sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass will receive either a procedure-specific Elan supplement formulation or a standard multivitamin and be followed for 12 months. The study will track incidence of micronutrient deficiencies, biochemical markers, clinical outcomes, and patient compliance. Investigators will collect laboratory tests and clinical data at scheduled follow-up visits to compare nutritional status and tolerability between groups. The trial aims to determine whether tailored postoperative formulations reduce nutrient deficits and improve adherence compared with standard supplements.
Who should consider this trial
Good fit: Adults aged 18–65 who can consent, have no prior gastrointestinal surgery, and are scheduled for primary sleeve gastrectomy, Roux-en-Y, or one-anastomosis gastric bypass and willing to attend follow-up for 12 months are ideal candidates.
Not a fit: Patients with chronic conditions that affect nutrient metabolism or absorption (for example chronic kidney disease, inflammatory bowel disease, or liver insufficiency), those who are pregnant or planning pregnancy during the study, undergoing revisional bariatric surgery, with active malignancy, or recent investigational supplement use are unlikely to benefit from the protocol outcomes.
Why it matters
Potential benefit: If successful, tailored Elan supplements could reduce post-surgery micronutrient deficiencies and related complications compared with standard multivitamins.
How similar studies have performed: Procedure-specific bariatric supplements have a plausible rationale but robust randomized evidence demonstrating superiority over standard multivitamins is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible participants must be adults: * Aged 18 to 65 years * Capable of providing informed consent * Willing to comply with study procedures and follow-up visits over 12 months. * Candidates must have no prior history of MBS or gastrointestinal surgery and must be scheduled for one of the three aforementioned primary procedures. * Both male and female patients will be considered, and no restrictions will be placed based on ethnicity or socioeconomic status. Exclusion Criteria: Exclusion criteria include: * The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency. * Additional exclusion criteria include pregnancy or lactation at the time of enrollment * Plans for pregnancy within the study period * Active malignancy * Any use of investigational drugs or supplements within the past 30 days. * Patients undergoing revisional bariatric surgery or conversion procedures will also be excluded.
Where this trial is running
Alexandria, Alexandria Governorate
- The surgical department of Medical Research Institute Hospital, Alexandria University — Alexandria, Alexandria Governorate, 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.