Weight LossVITAGLPNCT07234916
Multivitamin Impact on Micronutrient Status in GLP-1 Users: A Randomized Trial
A study testing Multivitamin Supplementation in people with Weight Loss and Nutritional Deficiencies, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Weight Loss, Nutritional Deficiencies, GLP - 1
- What is being tested?
- Multivitamin Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Multivitamin Supplementation on Micronutrient Levels in GLP-1 Users: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read more
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
- Being tested
- Multivitamin Supplementation, Placebo
- Keywords
- weightloss, obesity, GLP-1, Nutritional deficiencies
- Medical subject headings
- Weight Loss, Malnutrition, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin SupplementationDietary supplement
Multivitamin Supplementation
PlaceboOther
Placebo vitamine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels
- Vitamin B12 (Reference range: 200-500 pmol/L)
- Vitamin D (Reference range: 50-200 nmol/L)
- Ferritin (Reference range: 30-388 μg/L)
- Folic acid (Reference range: 10-45 nmol/L)
Measured: 15 months
Secondary outcomes (1)
other micronutrient levels
Changes in other micronutrient levels from baseline to 12 months, including:
- Iron (10-30 μmol/L)
- Vitamin B1 (70-180 nmol/L)
- Vitamin B6 (35-110 nmol/L)
- Zinc (10-18 μmol/L)
- Magnesium (0.70-1.05 mmol/L)
- Calcium:
Total serum calcium: 2.15-2.55 mmol/L) Ionized calcium: 1.16-1.32 mmol/L PTH (Parathyroid Hormone) (1.6-6.9 pmol/L)
Changes in additional iron-related functional markers:
- Transferrin (2.0-3.6 g/L)
- Transferrin saturation (20-45%)
- Total iron binding capacity 2. Changes in hematological parameters:
- Hemoglobin (Female: 7.5-10.0 mmol/L; Male: 8.5-11.0 mmol/L)
- Mean Corpuscular Volume (MCV) (80-100 fL)
- HbA1c (4.0-6.0% (20-42 mmol/mol)) Inflammation and protein status
- C-reactive protein (CRP): <10 mg/L
- Albumin: 35-50 g/L Incidence of clinically significant deficiencies requiring intervention Correlation between weight loss parameters (%TWL, %EWL) and changes in micronutrient levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start16 Dec 2025 (estimated)
- Primary completion16 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- weightworks Clinic
- Responsible party
- Principal investigator, Bart Torensma, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234916
- Sponsor's protocol ID
- GLP-1-RCT-2025
- Other IDs
- ABR 2025 GLP
- Acronym
- VITAGLP
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will be responsible for the data analysis. The analysis will be performed on a blinded data set after medical/scientific review has been completed, all protocol violations have been identified, and the data set has been declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and performed according to Good Clinical Practice guidelines, Data Protection Directive certificate and complies with Title 21 CFR Part 11. Furthermore, the datacenter where all the research data is stored is ISO27001, ISO9001 certified and the Dutch NEN7510 certified.
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.
PubMed 38454010Friedrichsen 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.
PubMed 33269530Mechanick 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.
PubMed 39295512He 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.
PubMed 39040467Liu 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.
PubMed 36568085Sargeant 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.
PubMed 31565876Gentinetta 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.
PubMed 39722834Christensen 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.
PubMed 39175746Moiz 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.
PubMed 39892489
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multivitamin Supplementation on Micronutrient Levels in GLP-1 Users: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07234916
- Acronym / sponsor ID
- VITAGLP / GLP-1-RCT-2025
- Conditions
- Weight Loss, Nutritional Deficiencies, GLP - 1, Obese Patients
- Keywords
- weightloss, obesity, GLP-1, Nutritional deficiencies
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- weightworks Clinic
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Multivitamin Supplementation) | Experimental | Dietary Supplement: Multivitamin SupplementationParticipants 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. |
| Group B (Placebo) | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin SupplementationMultivitamin Supplementation | Dietary supplement | Group A (Multivitamin Supplementation) |
| PlaceboPlacebo vitamine | Other | Group B (Placebo) |
Primary outcome
serum levels
Time frame: 15 months
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)
1 secondary outcome
other micronutrient levels
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 38454010Bettadapura 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.
- Results publication: PubMed 33269530Friedrichsen 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.
- Results publication: PubMed 39295512Mechanick 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.
- Results publication: PubMed 39040467He 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.
- Results publication: PubMed 36568085Liu 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.
- Results publication: PubMed 31565876Sargeant 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.
- Results publication: PubMed 39722834Gentinetta 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.
- Results publication: PubMed 39175746Christensen 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.
- Results publication: PubMed 39892489Moiz 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.
- Individual participant dataSharing planned: Yes. The investigator will be responsible for the data analysis. The analysis will be performed on a blinded data set after medical/scientific review has been completed, all protocol violations have been identified, and the data set has been declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and performed according to Good Clinical Practice guidelines, Data Protection Directive certificate and complies with Title 21 CFR Part 11. Furthermore, the datacenter where all the research data is stored is ISO27001, ISO9001 certified and the Dutch NEN7510 certified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin Supplementation in people with Weight Loss and Nutritional Deficiencies, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum levels (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234916, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.