Status:
RECRUITING
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
Lead Sponsor:
General Committee of Teaching Hospitals and Institutes, Egypt
Conditions:
Micronutrient Deficiencies
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 capa...
Detailed Description
Primary Objectives: • Evaluate the efficacy of daily Balance multivitamin tablets in reducing the incidence of vitamin and mineral deficiencies among patients undergoing treatment with GLP-1 receptor...
Eligibility Criteria
Inclusion
- • Adults aged 18-65 years.
- BMI ≥ 30 kg/m² (obesity), or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension).
- Currently using a GLP-1 receptor agonist medication for weight management (e.g., semaglutide or liraglutide) and planning to continue it for the next year as part of their weight loss regimen.
Exclusion
- • Any pre-existing condition that affects nutrient absorption or metabolism (e.g., malabsorptive gastrointestinal disorders such as celiac disease or inflammatory bowel disease, prior bariatric surgery).
- Use of other weight loss medications (besides the GLP-1 RA) or use of high-dose vitamin/mineral supplements or other nutritional supplements that could influence vitamin/mineral status.
- Pregnancy or lactation (women of childbearing potential will undergo a pregnancy test and must agree to use contraception during the study).
- Known hypersensitivity or allergy to components of the Balance multivitamin formulation.
- Significant chronic illnesses (e.g., end-stage renal disease, advanced liver disease) that in the investigator's judgment would interfere with participation or outcomes of the study.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06981936
Start Date
May 15 2025
End Date
May 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Alexandria, Egypt