Vitamin D for Heart Attack

(TARGET-D Trial)

Overseen By Patti Spencer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Hypersensitivity to vitamin D, Hypercalcemia, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether managing vitamin D levels can reduce heart problems in individuals who recently experienced a heart attack. Participants will receive either standard care or vitamin D level adjustments with Vitamin D3 supplements. It suits those who had a heart attack within the last month, have not been taking much vitamin D, and receive follow-up care at an Intermountain Healthcare facility. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment benefits a broader range of patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on vitamin D levels and does not mention other medications.

What is the safety track record for Vitamin D3?

Research shows that Vitamin D3 is usually safe for consumption. Studies have found that taking Vitamin D is linked to a lower risk of death from any cause compared to not taking it. Some research also suggests it might slightly reduce the risk of major heart problems. However, evidence indicates that taking calcium with Vitamin D could slightly increase the risk of heart attacks. Overall, Vitamin D3 is considered safe and is often used to support bone health and other conditions. As this trial is in its late phase, the researchers have increased confidence in the treatment's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Vitamin D3 for heart attack prevention because it offers a potentially simple and natural way to improve heart health. Unlike other treatments that might involve more complex medications or invasive procedures, Vitamin D3 works by potentially improving cardiovascular health through maintaining optimal vitamin D levels. This approach is particularly appealing because Vitamin D3 is a naturally occurring vitamin that many people are already familiar with, and it could be an easy addition to a patient's routine, potentially leading to better heart outcomes with fewer side effects.

What evidence suggests that Vitamin D3 might be an effective treatment for heart attack patients?

This trial will compare Vitamin D3 supplementation with standard care to assess its impact on heart health after a heart attack. Research suggests that vitamin D3 might help reduce the risk of heart problems. One study found that people who took vitamin D supplements had a 19% lower risk of heart attacks. However, another study showed that vitamin D3 did not significantly change the overall rate of major heart issues compared to a placebo. Some research also indicates a decrease in heart attack risk with vitamin D. Overall, the findings are mixed, but some evidence suggests that vitamin D3 might benefit heart health after a heart attack. ^{5 6 7 8 9}

Who Is on the Research Team?

Joseph B Muhlestein, MD

Principal Investigator

Intermountain Heart Institute

Heidi T May, PhD, MSPH

Principal Investigator

Intermountain Heart Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a heart attack in the past month, are not on high doses of vitamin D, and can follow up at an Intermountain Healthcare facility. It's not for those with certain psychiatric illnesses, pregnant or breastfeeding women without contraception, recent other trial participants, or people with terminal illnesses.

Inclusion Criteria

Patients who receive follow-up care at an Intermountain Healthcare facility

Patients willing to provide informed consent and participate in follow-up visits

I have been taking less than 1000 IU of vitamin D daily for the last 3 months.

Exclusion Criteria

My doctor expects I have less than 12 months to live due to my illness.

I have taken more than 1000 IU of vitamin D daily in the last 3 months.

Subjects who have participated in previous investigational interventional studies within 30 days of the current study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clinical management of 25[OH] Vit D levels with individualized dosing to achieve target levels

3 months

1 visit (in-person) every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up testing at 1 year

1 year

1 visit (in-person) at 1 year

Long-term follow-up

Participants' electronic records are queried for outcomes and vitamin D levels

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin D3

Trial Overview The study tests if normalizing Vitamin D levels (>40 ng/mL) in heart attack patients reduces cardiovascular events. Participants will be randomly divided into two groups: one receiving standard care and the other managed to achieve targeted Vitamin D levels.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients randomized to the treatment arm will have a 25\[OH\] Vit D test performed, a sample taken and stored for future tests, and completion of a PHQ-9 depression survey. If at baseline a patient has a 25\[OH\] Vit D \>40 ng/mL then follow-up testing will occur 1 year from baseline and the patient will continue current treatment strategy (no supplementation or current supplementation dosage). If baseline 25\[OH\] Vit D levels are \<40 ng/mL then the patient will initiate or increase dose and return in 3 months (±15 days) to determine 25\[OH\] Vit D level. At 3 months, if 25\[OH\] Vit D \>40 ng/mL then current dose should be kept and the patient will return in 1 year for follow-up testing. However, if 25\[OH\] Vit D \<40 ng/mL then patients should double current dose and test again in 3 months. This should occur until 25\[OH\] Vit D reaches a level \>40 ng/mL and once achieved, the patient will return in 1 year for follow-up 25\[OH\] Vit D testing.

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to the standard of care arm will have a 25\[OH\] Vit D test performed, a sample taken and stored for future tests, and completion of a PHQ-9 depression survey at baseline and at study conclusion. No other contact is planned with the standard of care patients. Follow-up will be done by the querying of electronic records, which includes any 25\[OH\] Vit D testing, use of vitamin D supplementation, and outcomes.

Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in United States as Vitamin D3 for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Canada as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Japan as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in China as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Switzerland as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Citations

1. e-enm.org e-enm.org/journal/view.php?number=2371

Cardiovascular Impact of Calcium and Vitamin D ... ... VITamin D and OmegA-3 TriaL; MI, myocardial infarction. Download Table Download Table: The VITamin D and OmegA-3 TriaL (VITAL) trial was an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5290441/

Effectiveness of Vitamin D Supplementation for ... Effects of vitamin D supplementation on markers of vascular function after myocardial infarction - a randomised controlled trial. Int J ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0261561425001116

Real-world evidence for an association of vitamin D ... In addition, we observed a 10 % reduction in the risk of IHD, which was lower than the 19 % reduction in the hazard of myocardial infarction reported in the D- ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2018/11/08/22/42/VITAL

Vitamin D and Omega-3 Trial - VITAL The primary CV outcome of CV death, nonfatal myocardial infarction (MI), or stroke, for vitamin D3 vs. placebo, was 3.1% vs. 3.2%, hazard ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280623005364

Cardiovascular and Cerebrovascular Outcomes With ... This study is also the first large-scaled RCT—to our knowledge—to demonstrate a significant decrease in the risk of myocardial infarction with the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10146299/

Vitamin D Supplementation and Its Impact on Mortality ... Vitamin D supplementation was associated with a lower risk of ACM (OR: 0.95 [95%CI 0.91–0.99] p = 0.013), was close to statistical significance ...

7. bmj.com bmj.com/content/381/bmj-2023-075230

Vitamin D supplementation and major cardiovascular events Vitamin D supplementation might reduce the incidence of major cardiovascular events, although the absolute risk difference was small and the confidence ...

8. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2735646

Vitamin D Supplementation and Cardiovascular Disease ... Vitamin D supplementation was not associated with reduced risks of major adverse cardiovascular events, myocardial infarction, stroke, cardiovascular disease ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523047391

Cardiovascular disease and vitamin D supplementation Risk of fatal cardiac failure was lower in the vitamin D group than in the no–vitamin D group (adjusted HR: 0.70; 95% CI: 0.53, 0.91; P = 0.009), but risk of ...