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Study identifier: NCT07021248 Synced from ClinicalTrials.gov · July 29, 2026
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A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery

Condition: Micronutrient Status  ·  Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

PhasePhase 4
Planned participants249
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Mohamed Ashour, Ph.D. (Professor)  ·  +201002600970  ·  mohamed.ashour@alexu.edu.eg

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Locations (1)

The surgical department of Medical Research Institute Hospital, Alexandria UniversityAlexandria, Egypt, EgyptRecruiting

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Source record: clinicaltrials.gov/study/NCT07021248