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New treatment option for Micronutrient Status
Official title A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery
ClinicalTrials.gov ID: NCT07021248
What this study is testing
- What it's testing
- Obesity is a complex, multifactorial chronic disease with an escalating global incidence, impacting over 650 million adults worldwide. It is closely linked to a variety of metabolic, cardiovascular, and musculoskeletal diseases, and is a leading contributor to preventable morbidity and mortality.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Patients must meet established surgical indications as defined by the International Federation for the Surgery of Obesity and Metabolic Disorders...
- or a BMI greater than 35 kg/m² irrespective of comorbidities.
You likely can't join if
- 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...
- Patients who are already receiving high-dose vitamin B6 supplementation or have abnormal preoperative B6 levels will be excluded.
See the full eligibility 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...
- 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 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...
- Patients who are already receiving high-dose vitamin B6 supplementation or have abnormal preoperative B6 levels will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Alexandria, Egypt, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexandria, Egypt, Egypt. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.