Multivitamin Impact on Micronutrient Status in GLP-1 Users: A Randomized Trial

NCT07234916 | Enrolling By Invitation

• 2 other identifiers: GLP-1-RCT-2025ABR 2025 GLP
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Weight Loss; Nutritional Deficiencies; GLP - 1; Obese Patients

Keywords

weightloss; obesity; GLP-1; Nutritional deficiencies

Outcome Measures

Primary Outcomes (1)

• serum levels

  1. Vitamin B12 (Reference range: 200-500 pmol/L) 2. Vitamin D (Reference range: 50-200 nmol/L) 3. Ferritin (Reference range: 30-388 μg/L) 4. Folic acid (Reference range: 10-45 nmol/L)

  15 months

Secondary Outcomes (1)

• other micronutrient levels

  12 months

Other Outcomes (6)

• Weight loss

  12 months

• GLP adherence

  12 months

• diet

  12 months

Study Arms (2)

Group A (Multivitamin Supplementation)

EXPERIMENTAL

Participants in this group will receive a daily multivitamin supplement formulated to provide comprehensive micronutrient support. The supplement will be taken once daily with a meal for the 12-month intervention period following randomization.

Dietary Supplement: Multivitamin Supplementation

Group B (Placebo)

PLACEBO COMPARATOR

Participants in this group will receive a matching placebo that is identical in appearance, taste, and packaging to the active multivitamin supplement. The placebo will be taken once daily with a meal for the 12-month intervention period following randomization.

Other: Placebo

Interventions

Multivitamin Supplementation DIETARY_SUPPLEMENT

Multivitamin Supplementation

Group A (Multivitamin Supplementation)

Placebo OTHER

Placebo vitamine

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• weightworks Clinic: collaborator

Study Sites (2)

WeightWorks Clinics

Amersfoort, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Moiz A, Filion KB, Tsoukas MA, Yu OH, Peters TM, Eisenberg MJ. Mechanisms of GLP-1 Receptor Agonist-Induced Weight Loss: A Review of Central and Peripheral Pathways in Appetite and Energy Regulation. Am J Med. 2025 Jun;138(6):934-940. doi: 10.1016/j.amjmed.2025.01.021. Epub 2025 Jan 31.

  PMID: 39892489 RESULT

MeSH Terms

Conditions

Weight Loss; Malnutrition; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical epidemiologist

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: November 19, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

NL (2)