Multivitamins Fail to Reduce Heart Risk in Patients With Diabetes and Prior Heart Attack

High-dose oral multivitamins and multiminerals (OMVMs) do not reduce major cardiovascular events in patients with diabetes and a prior heart attack, according to one study.¹

A new clinical trial finds no cardiovascular benefit from high-dose multivitamins, with or without chelation therapy, in patients with diabetes and past myocardial infarction (MI). | Image credit: Praewpan - stock.adobe.com

The randomized clinical trial is published in JAMA Internal Medicine.

“The primary aim of the trial was to rigorously test the clinical effectiveness of EDTA [edetate disodium] chelation, which had been used clinically for decades for cardiovascular prevention on the basis of anecdotal evidence alone and despite the negative results of several small, randomized clinical trials,” wrote the researchers of the study. “The lack of definitive evidence regarding clinical effectiveness was considered a public health problem by the NIH [National Institutes of Health] which provided funding for the trial.”

Most patients with type 2 diabetes (T2D) lack key vitamins and micronutrients, with vitamin D deficiency affecting 60.45% of patients, according to research.² Women with T2D also have a higher prevalence of micronutrient deficiencies compared with men.

The current study was conducted across 88 sites in the US and Canada, enrolling participants 50 years and older who had experienced a myocardial infarction [MI] at least 6 weeks prior.¹ Between September 2016 and December 2020, 1000 participants were randomly assigned to receive either an OMVM regimen (6 daily caplets containing 28 components) or a matching placebo, along with either weekly infusions of an EDTA-based chelation solution or a placebo infusion. The study’s primary outcome was a composite measure of all-cause mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for unstable angina, with data collected through June 2023 to evaluate long-term effects.

In total, 500 patients were assigned to the active OMVM group and 500 to the placebo group. The median (IQ) age was 67 (60-72) years, and 73% of participants were male. Over a median (IQR) follow-up period of 48 (34-58) months, the primary end point occurred in 35% of participants in both the active OMVM and placebo groups (HR, 0.99; 95% CI, 0.80-1.22; P = .92), indicating no significant difference in cardiovascular outcomes.

Similarly, subgroup analyses comparing EDTA chelation combined with OMVM vs placebo showed no significant reductions in events, with 5-year event rates remaining similar across groups. While not statistically significant, the data also suggested a numerically higher incidence of MI, stroke, and cardiovascular mortality in the active OMVM group compared with placebo, reinforcing the conclusion that high-dose multivitamin supplementation provides no clear cardiovascular benefit in this high-risk population.

However, the researchers noted that several limitations should be considered when interpreting the findings. The study was conducted during the COVID-19 pandemic, which may have influenced participants' dietary habits and lifestyle factors, though this likely affected both groups equally. Adherence to the OMVM regimen was imperfect, mirroring trends observed in the first trial. Additionally, while the original study suggested an 11% relative benefit for the primary endpoint, the study was not powered to detect or exclude an effect of this magnitude with certainty. Lastly, the lack of measurable differences in certain minerals between the active and placebo OMVM groups raised questions about nutrient absorption and bioavailability.

Despite these limitations, the researchers believe the findings challenge the idea that OMVMs play a protective role in heart health, even when combined with EDTA-based chelation therapy.

“The results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, the use of high-dose OMVMs alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events,” wrote the researchers.

References

1. Ujueta F, Lamas GA, Anstrom KJ, et al. Multivitamins after myocardial infarction in patients with diabetes: A randomized clinical trial. JAMA Intern Med. Published online March 3, 2025. doi:10.1001/jamainternmed.2024.8408

2. Klein H. Most patients with type 2 diabetes have vitamin D deficiency, study suggests. AJMC^®. January 28, 2025. Accessed March 3, 2025. https://www.ajmc.com/view/most-patients-with-type-2-diabetes-have-vitamin-d-deficiency-study-suggests