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Vitamin

Vitamin D for Heart Attack (TARGET-D Trial)

Phase 4

Waitlist Available

Led By Heidi T May, PhD, MSPH

Research Sponsored by Intermountain Health Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients not taking or taking <1000 IU of vitamin D daily within the last 3 months

Patients who have undergone angiography for a MI (troponin positive [>0.04 ng/mL] and ACS diagnosis) within the past month

Must not have

Patients with systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a reduced (<12 months) life expectancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test whether raising vitamin D levels in people who have had a heart attack can reduce the risk of having another heart-related problem.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Vitamin D3 supplementation may cause side effects like hypercalcemia (high calcium levels), which could lead to kidney stones or bone pain. However, these are generally rare when Vitamin D is taken as directed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I had an angiography for a heart attack confirmed by high troponin levels last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cholecalciferol

FDA approved

0 / 3Eligibility criteria met