Multivitamin Impact on Micronutrient Status in GLP-1 Users: A Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multivitamin Supplementation, Placebo.
- Who it may be relevant to
- Registry conditions: Weight Loss, Nutritional Deficiencies, GLP - 1, Obese Patients. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Multivitamin Supplementation on Micronutrient Levels in GLP-1 Users: A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
Rationale: Glucagon-Like Peptide-1 (GLP-1) receptor agonists have emerged as effective treatments for obesity and associated medical conditions. However, patients may be at risk of micronutrient deficiencies during therapy due to reduced appetite, altered gastrointestinal physiology, and weight loss. Multivitamin supplementation is commonly prescribed to mitigate these risks, but the necessity and efficacy of multivitamin use in GLP-1 users remain debatable, as some clinicians advocate for routine supplementation while others do not. Objective: To assess the differences in micronutrient levels between patients who use multivitamin supplements while on GLP-1 therapy and those who do not, to provide evidence on the necessity and benefits of supplementation. Study Design: Randomized, double-blind, placebo-controlled trial. Study Population: Adults with obesity (BMI ≥30 kg/m² or ≥27 kg/m² with obesity-associated medical problems) currently using GLP-1 receptor agonists for at least 3 months with stable dosing. Intervention: * Group A (Intervention): Multivitamin supplementation while on GLP-1 therapy * Group B (Control): Matching placebo while on GLP-1 therapy Main Study Parameters/Endpoints: The primary outcomes are the differences in serum levels of Vitamin B12, Vitamin D, and Ferritin between the multivitamin and placebo groups after 12 months of supplementation while on GLP-1 therapy. Nature and Extent of the Burden and Risks: Participants will undergo blood sampling at four timepoints: baseline (before starting GLP-1 therapy), at randomization (3 months of stable GLP-1 therapy), and at 6 and 12 months post-randomization. The risks associated with the study are minimal and primarily related to blood sampling and potential side effects of multivitamin supplementation. The burden includes time commitment for study visits and daily supplement intake.
Interventions
- Dietary supplement Multivitamin Supplementation
Multivitamin Supplementation - Other Placebo
Placebo vitamine
Primary outcome measures
- serum levels [Time frame: 15 months]
Secondary outcome measures (1)
- other micronutrient levels [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 to 70 years.
- Start with the use of Tirzepatide GLP-1 receptor agonists and for at least 3 months with stable dosing before randomization.
- BMI ≥30 kg/m² or ≥27 kg/m² with obesity-associated medical problems (such as type 2 diabetes, hypertension, or dyslipidemia) at the start of GLP-1 therapy
- Willing and able to provide informed consent
- Able to comply with study procedures and follow-up visits
- Own vitamins should be completely discontinued 2 weeks before the start
Exclusion criteria
- Known allergy or hypersensitivity to any components of the multivitamin supplement
- Current use of other vitamin or mineral supplements
- Pregnancy or planning pregnancy during the study period
- Patients who follow a vegan diet.
- Active malignancy or ongoing cancer treatment
- Severe kidney disease (eGFR <30 mL/min/1.73m²)
- Severe liver disease (Child-Pugh C)
- History of metabolic bariatric surgery
- Participation in other clinical trials within the past 3 months
- Any condition that, in the investigator's opinion, would interfere with study participation or compromise patient safety
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- WeightWorks Clinics — Amersfoort
- Erasmus MC — Rotterdam
Publications
- Bettadapura S, Dowling K, Jablon K, Al-Humadi AW, le Roux CW. Changes in food preferences and ingestive behaviors after glucagon-like peptide-1 analog treatment: techniques and opportunities. Int J Obes (Lond). 2025 Mar;49(3):418-426. doi: 10.1038/s41366-024-01500-y. Epub 2024 Mar 7. PMID 38454010
- Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3. PMID 33269530
- Mechanick JI, Butsch WS, Christensen SM, Hamdy O, Li Z, Prado CM, Heymsfield SB. Strategies for minimizing muscle loss during use of incretin-mimetic drugs for treatment of obesity. Obes Rev. 2025 Jan;26(1):e13841. doi: 10.1111/obr.13841. Epub 2024 Sep 19. PMID 39295512
- He L, Li Q, Yang Y, Li J, Luo W, Huang Y, Zhong X. Pharmacovigilance study of GLP-1 receptor agonists for metabolic and nutritional adverse events. Front Pharmacol. 2024 Jul 8;15:1416985. doi: 10.3389/fphar.2024.1416985. eCollection 2024. PMID 39040467
- Liu L, Chen J, Wang L, Chen C, Chen L. Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Front Endocrinol (Lausanne). 2022 Dec 7;13:1043789. doi: 10.3389/fendo.2022.1043789. eCollection 2022. PMID 36568085
- Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. PMID 31565876
- Gentinetta S, Sottotetti F, Manuelli M, Cena H. Dietary Recommendations for the Management of Gastrointestinal Symptoms in Patients Treated with GLP-1 Receptor Agonist. Diabetes Metab Syndr Obes. 2024 Dec 19;17:4817-4824. doi: 10.2147/DMSO.S494919. eCollection 2024. PMID 39722834
- Christensen S, Robinson K, Thomas S, Williams DR. Dietary intake by patients taking GLP-1 and dual GIP/GLP-1 receptor agonists: A narrative review and discussion of research needs. Obes Pillars. 2024 Jul 25;11:100121. doi: 10.1016/j.obpill.2024.100121. eCollection 2024 Sep. PMID 39175746
Identifiers
NCT: NCT07234916 · GLP-1-RCT-2025 · ABR 2025 GLP