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

NCT07021248 | Recruiting Phase 4

• 1 other identifier: RCT Micronutrient Status
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Micronutrient Status

Keywords

Procedure-Specific Bariatric Supplements; Micronutrient Status; Vitamin B6 Hypervitaminosis; Metabolic and Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• The prevalence of vitamin B6 hypervitaminosis

  Defined as a serum pyridoxal 5'-phosphate (PLP) concentration greater than 100 nmol/L, measured at 6 and 12 months postoperatively.

  Measured at 6 and 12 months postoperatively.

Secondary Outcomes (7)

• Prevalence of vitamin B6 deficiency

  Measured at 6 and 12 months postoperatively.

• Serum concentrations of other key micronutrients

  Measured at 6 and 12 months postoperatively.

• Incidence of other micronutrient deficiencies

  measured at 6 and 12 months postoperatively.

• Relationship between supplement adherence and clinical outcomes

  measured at 6 and 12 months postoperatively.

• Trends in micronutrient status (hemoglobin, ferritin, vitamin B12, folate, vitamin D, calcium, magnesium, parathyroid hormone, and zinc)

  measured at 6 and 12 months postoperatively.

Study Arms (3)

Elan Believe

ACTIVE COMPARATOR

Sleeve gastrectomy specific bariatric supplement

Dietary Supplement: Elan Believe

Elan Compass

ACTIVE COMPARATOR

Roux en Y gastric bypass specific bariatric supplement

Dietary Supplement: Elan Compass

Elan Supreme

ACTIVE COMPARATOR

One anastomosis gastric bypass specific bariatric supplement

Dietary Supplement: Elan Supreme

Interventions

Elan Believe DIETARY_SUPPLEMENT

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.

Elan Believe

Elan Compass DIETARY_SUPPLEMENT

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.

Elan Compass

Elan Supreme DIETARY_SUPPLEMENT

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.

Elan Supreme

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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
• Patients who are already receiving high-dose vitamin B6 supplementation or have abnormal preoperative B6 levels will be excluded.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt, 21531, Egypt

RECRUITING

Central Study Contacts

Mohamed Ashour, Ph.D. (Professor)

CONTACT

+201002600970; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Model Details: Participants will receive a specialized Elan bariatric supplement matched to the type of MBS they undergo. Each formulation, Elan Believe for SG, Elan Compass for RYGB, and Elan Supreme for OAGB, addresses the distinct micronutrient absorption profiles and physiological alterations associated with each surgical procedure. Importantly, all three formulations contain a standardized dose of vitamin B6 of 400 micrograms, facilitating valid comparisons of postoperative B6 levels across procedures. Supplementation will commence after one month postoperatively and continue for 12 months. Participants will be instructed to take one tablet daily with food. In addition to the assigned Elan supplement, all participants will receive standard calcium and cholecalciferol supplementation per institutional protocols.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Whole study period
• Access Criteria: Ask contact person

Locations

EG (1)