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Vitamin

Vitamin D3 for Heart Attack (TARGET-D Trial)

Phase 4
Recruiting
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
Not taking or taking <1000 IU of vitamin D daily within the last 3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented event, up to 48 months
Awards & highlights

TARGET-D 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.

Eligible Conditions
  • Heart Attack
  • Death
  • Stroke
  • Heart Failure

TARGET-D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have not been taking enough vitamin D every day for the past 3 months.

TARGET-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented event, up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented event, up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident

TARGET-D 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

Find a Location

Who is running the clinical trial?

Intermountain Health Care, Inc.Lead Sponsor
137 Previous Clinical Trials
1,962,220 Total Patients Enrolled
Heidi T May, PhD, MSPHPrincipal InvestigatorIntermountain Heart Institute
Joseph B Muhlestein, MDPrincipal InvestigatorIntermountain Heart Institute
9 Previous Clinical Trials
40,889 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies open to participants in this experiment?

"Affirmative. Data provided on clinicaltrials.gov confirms that this trial, which was first published on April 3rd 2017, is actively recruiting patients. 890 participants are required from one medical site to complete the study."

Answered by AI

What health issues is Vitamin D3 proven to ameliorate?

"Vitamin D3 is the most typical treatment for calcium deficiency, however it can also be efficacious in treating conditions like fracture, spine fracture and post menopausal women."

Answered by AI

Has the FDA approved Vitamin D3 for use?

"Given the success of its Phase 4 trial, Vitamin D3 has been conferred a score of 3 in terms of safety."

Answered by AI

How many participants have been officially accepted into this clinical trial?

"Yes, the information available on clinicaltrials.gov attests to this trial's ongoing recruitment efforts. It was originally posted in April 2017 and has since been modified as recently as August 2022, with a goal of enrolling 890 patients at 1 site."

Answered by AI

Are there any previous works exploring the effects of Vitamin D3?

"Presently, 33 studies are inspecting Vitamin D3 with 14 of these trials in their culminating stage. Of the 155 locations running research on this vitamin, many reside in Boston, Massachusetts."

Answered by AI
~112 spots leftby Mar 2025