The Impact of Multivitamin Supplementation on Micronutrient Levels in GLP-1 Users: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- serum levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group A (Multivitamin Supplementation)
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.
干预措施: Multivitamin Supplementation (Dietary Supplement)
Group B (Placebo)
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.
干预措施: Placebo (Other)
结局指标
主要结局
serum levels
时间窗: 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)
次要结局
- other micronutrient levels(12 months)
研究者
Bart Torensma
Clinical epidemiologist
Erasmus Medical Center