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Can tailored supplements prevent vitamin overdose after bariatric surgery?

NCT ID NCT07021248

Knowledge-focused Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests whether giving people special supplements designed for their type of weight-loss surgery can help keep their vitamin levels healthy. After bariatric surgery, the body absorbs nutrients differently, which can lead to both deficiencies and, from too many supplements, vitamin B6 overdose. The trial will follow 249 adults for a year to see if these custom supplements reduce the risk of high or low vitamin levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elan Believe and Elan Compass bariatric supplements
What this could lead to
If successful, this could show that tailored supplements better manage vitamin and mineral levels after weight-loss surgery, reducing both deficiencies and overdoses.
What could go wrong
This is a Phase 4 trial with 249 participants, so results may not apply to everyone. The supplements are dietary, not drugs, so the impact may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

249 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Micronutrient status

Contacts and locations

Locations

  • The surgical department of Medical Research Institute Hospital, Alexandria University

    Alexandria, Egypt, 21531, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.