A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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. Metabolic and Bariatric Surgery (MBS) stands out as the most effective long-term intervention for obesity, facilitating significant and sustained weight loss while also promoting remission of associated diseases. However, the anatomical and physiological alterations induced by MBS, including gastric restriction, bypass of absorptive surfaces, altered gastrointestinal transit, and reduced gastric acid production, significantly disrupt nutrient absorption and metabolism, placing patients at lifelong risk of micronutrient deficiencies or, conversely, hypervitaminosis resulting from excessive supplementation. Among these, Vitamin B6 imbalance has emerged as a significant yet under-recognized issue in post-MBS patients. Among the nutrients affected, vitamin B6 (pyridoxine) presents a unique challenge. Vitamin B6 functions as a coenzyme in amino acid metabolism, neurotransmitter synthesis, and immune regulation. Deficiencies in Vitamin B6 are well-documented and can manifest as glossitis, irritability, and peripheral neuropathy. Notably, B6-related neuropathy may clinically resemble Guillain-Barré syndrome in post-MBS patients. This anxiety surrounding deficiency symptoms often leads to the overconsumption of Vitamin B6, resulting in hypervitaminosis, which can also present with neurological manifestations such as sensory neuropathy and ataxia. The risk of hypervitaminosis is further exacerbated by the widespread use of high-dose multivitamin formulations post-surgery, many of which contain vitamin B6 at levels far exceeding the Recommended Dietary Allowance (RDA). For males, the RDA is 1.3 mg daily for those aged 19-50 years, increasing to 1.7 mg for those over 50. For females, the RDA is 1.3 mg for those aged 19-50 and 1.5 mg for those over 50. Yet some commercially available bariatric supplements exceed this level several-fold. Studies by Dogan et al. and Homan et al. emphasize the prevalence of vitamin B6 toxicity in post-MBS populations, largely attributable to inappropriate supplementation practices.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
Egypt
The surgical department of Medical Research Institute Hospital, Alexandria University
RECRUITING
Alexandria
Contact Information
Primary
Mohamed Ashour, Ph.D. (Professor)
mohamed.ashour@alexu.edu.eg
+201002600970
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 249
Treatments
Active_comparator: Elan Believe
Sleeve gastrectomy specific bariatric supplement
Active_comparator: Elan Compass
Roux en Y gastric bypass specific bariatric supplement
Active_comparator: Elan Supreme
One anastomosis gastric bypass specific bariatric supplement
Sponsors
Leads: General Committee of Teaching Hospitals and Institutes, Egypt

This content was sourced from clinicaltrials.gov

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