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RECRUITING
NCT06981936
PHASE4

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

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

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.

Official title: Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-05-15

Completion Date

2026-05

Last Updated

2025-09-16

Healthy Volunteers

Yes

Interventions

DRUG

Balance Tablet

Each Balance tablet contains a broad range of vitamins and trace minerals at doses designed to prevent deficiencies (including but not limited to vitamins A, B-complex, C, D, E, K, calcium, iron, zinc, magnesium, selenium, and others, per standard multivitamin composition).

DRUG

Control (placebo)

The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.

Locations (1)

Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility

Alexandria, Egypt