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Compensation: Varies

Number of Visits: 2

Duration: 3 months

890 Participants Needed

Vitamin D for Heart Attack
(TARGET-D Trial)

Overseen ByPatti 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 GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study evaluates whether achieving 25-hydroxyvitamin D (25\[OH\] Vit D) levels (\>40 ng/mL) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. Half of the patients will be randomized to receive standard of care and half will receive clinical management of 25\[OH\] Vit D levels.

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 data supports the effectiveness of the drug Vitamin D3 for heart attack prevention?

Research suggests that higher levels of vitamin D3 in the blood are linked to a lower risk of heart attacks. One study found that people with higher vitamin D3 levels had a significantly reduced risk of heart attacks compared to those with lower levels.¹ ² ³ ⁴ ⁵

Is Vitamin D3 safe for humans?

Vitamin D3 (cholecalciferol) is generally safe for humans when taken in recommended amounts, but doses beyond 600 to 800 IU daily are not advised for preventing heart disease. Very low or very high levels of vitamin D in the blood can be linked to health issues, including heart problems.¹ ² ⁶ ⁷ ⁸

How is Vitamin D3 different from other treatments for heart attack?

Vitamin D3 (cholecalciferol) is unique because it may improve vascular function and reduce inflammation, which could help protect the heart. Unlike other treatments that directly target heart attack symptoms, Vitamin D3 focuses on overall cardiovascular health by potentially improving arterial stiffness and inflammation.¹ ² ⁶ ⁹ ¹⁰

Research Team

Joseph B Muhlestein, MD

Principal Investigator

Intermountain Heart Institute

Heidi T May, PhD, MSPH

Principal Investigator

Intermountain Heart Institute

Eligibility Criteria

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

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

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

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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

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Timeline

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

Treatment Details

Interventions

Vitamin D3

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 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 CareActive Control1 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: