Daily Balance multivitamin to prevent micronutrient shortages for people on GLP-1 weight-loss medications
Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss
We will test whether taking a daily Balance multivitamin prevents vitamin and mineral shortages in adults using GLP-1 medicines for weight loss.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06981936 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled phase 4 trial will enroll adults using GLP-1 receptor agonists for weight management and follow them for 12 months while they take either a daily Balance multivitamin tablet or a placebo. The main outcome is the incidence of laboratory-defined vitamin and mineral deficiencies at 12 months, and secondary outcomes include changes in serum B12, 25-hydroxyvitamin D, ferritin, and folate, measures of body weight and BMI, occurrence of elevated vitamin levels, and adherence to the tablet regimen. Participants meeting eligibility criteria will be randomized and undergo baseline and 12-month laboratory and anthropometric assessments at the Medical Research Institute Hospital, Alexandria University. The trial excludes people with conditions or prior surgeries that affect nutrient absorption and those using other interfering supplements or weight-loss drugs.
Who should consider this trial
Good fit: Adults aged 18–65 with obesity (BMI ≥30, or ≥27 with an obesity-related condition) who are currently using and plan to continue a GLP-1 receptor agonist for weight management are ideal candidates.
Not a fit: People with malabsorptive conditions or prior bariatric surgery, those taking high-dose vitamin/mineral supplements or other weight-loss drugs, and pregnant or breastfeeding women are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the intervention could reduce the risk of vitamin and mineral deficiencies in people taking GLP-1 weight-loss drugs and help prevent related health problems.
How similar studies have performed: While micronutrient deficiencies are well documented after bariatric surgery, few randomized trials have tested targeted multivitamins specifically in patients on GLP-1 receptor agonists, so this approach is relatively novel in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 Criteria: * • 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.
Where this trial is running
Alexandria
- Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: M Hany Ashour, MD Alexandria University
- Email: mohamed.ashour@alexu.edu.eg
- Phone: +20 100 2600970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.