Clinical Trial

This Randomized Trial Aims to Investigate the Efficacy of Balanced Nutritional Tablets-Comprehensive Multivitamin and Mineral Supplements- in Preventing Micronutrient Deficiencies Among Patients Utilizing GLP-1 RAs for Weight Loss in Comparison to a Placebo Control

Recruiting Phase 4
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Record status
This record was last updated September 16, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic (semaglutide) and Saxenda (liraglutide), are gaining traction in treating obesity and its associated diseases due to their capacity to facilitate substantial weight loss through mechanisms such as appetite suppression and delayed gastric emptying. Clinical trials have consistently shown that patients prescribed GLP-1 RAs can achieve significant body weight reductions when combined with appropriate dosing and lifestyle modifications. However, the chronic appetite suppression and reduced caloric intake associated with prolonged GLP-1 RA use may increase the risk of micronutrient deficiencies, paralleling the biochemical changes observed after metabolic and bariatric surgery (MBS). In MBS cohorts, insufficient dietary intake coupled with malabsorption frequently results in deficiencies of essential vitamins and minerals, even in patients adhering to standard multivitamin regimens. Research has demonstrated that high-dose specialized multivitamin supplementation can substantially lower the incidence of postoperative micronutrient deficiencies in MBS patients. This raises the possibility that proactive nutrient supplementation might similarly benefit individuals undergoing weight loss with GLP-1 RAs, although this hypothesis remains to be empirically validated. To address this gap, this randomized trial aims to investigate the efficacy of Balanced nutritional tablets-comprehensive multivitamin and mineral supplements- in preventing micronutrient deficiencies among patients utilizing GLP-1 RAs for weight loss in comparison to a placebo control. Moreover, the study will assess changes in key nutrient biomarkers and relevant clinical outcomes over 12 months.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-17.
Status change: Not Yet Recruiting → Recruiting 2025-09-10
Trial Details
NCT Number NCT06981936
Lead Sponsor General Committee of Teaching Hospitals and Institutes, Egypt
Conditions Micronutrient Deficiencies
Enrollment 150 participants
Start Date 2025-05-15
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-09-16