NCT07021248

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To address this, the Elan series of bariatric-specific supplements (Believe, Compass, and Supreme) was developed with standardized and conservative B6 dosing (400 micrograms per day), approximately 29% of the adult RDA. Each formulation is tailored to the nutritional demands of a specific MBS procedure, while maintaining a uniform B6 dose to facilitate direct comparisons of B6 status across surgical types. To date, no prospective, randomized study has evaluated the effect of procedure-specific supplementation on the risk of vitamin B6 hypervitaminosis in post-bariatric patients. This trial aims to fill that gap by comparing standardized B6 supplementation outcomes across three common MBS procedures: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). In addition to assessing the prevalence of B6 toxicity and deficiency, the study will evaluate broader micronutrient status, anthropometric outcomes, and adherence to supplementation. Findings from this trial are expected to inform the design of safer, procedure-matched supplementation protocols for post-MBS care.

Conditions

• Micronutrient Status

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elan Believe	Participants will receive a specialized Elan bariatric supplement matched to the type of MBS they undergo. Elan Believe for SG addresses the distinct micronutrient absorption profiles and physiological alterations associated with this surgical procedure. Importantly, all formulations contain a standardized dose of vitamin B6 of 400 micrograms, facilitating valid comparisons of postoperative B6 levels across procedures.
DIETARY_SUPPLEMENT	Elan Compass	Participants will receive a specialized Elan bariatric supplement matched to the type of MBS they undergo. Elan Compass for RYGB addresses the distinct micronutrient absorption profiles and physiological alterations associated with this surgical procedure. Importantly, all formulations contain a standardized dose of vitamin B6 of 400 micrograms, facilitating valid comparisons of postoperative B6 levels across procedures.
DIETARY_SUPPLEMENT	Elan Supreme	Participants will receive a specialized Elan bariatric supplement matched to the type of MBS they undergo. Elan Supreme for OAGB addresses the distinct micronutrient absorption profiles and physiological alterations associated with this surgical procedure. Importantly, all formulations contain a standardized dose of vitamin B6 of 400 micrograms, facilitating valid comparisons of postoperative B6 levels across procedures.

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-13
• Last updated: 2025-09-16

Locations

1 site across 1 country: Egypt