Vitamin D Deficiency Treatment Outcomes After Non-ST-Segment Elevation Myocardial Infarction

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The leading cause of death in the world is due to cardiovascular events, which originate from coronary artery stenosis therefore it affects myocardial blood flow and finally may cause infarction. Atherosclerosis is the most debatable hypothesis in coronary stenosis. Scientists think body inflammation is one of the main etiologies. There are many factors affect this inflammatory process, which Vitamin D is one of them. Vitamin D deficiency has been linked to various inflammatory diseases. However, the mechanism by which vitamin D reduces inflammation remains poorly understood. Vitamin D deficiency is pandemic around the world with 30-50% prevalence in adult population and several evidences advocated its association with immune-based disease. Additionally, there are some study suggesting patients who suffered from myocardial infarction have lower serum vitamin D level. It has been revealed Vitamin D deficiency has numerous major drawbacks on cardiovascular system. Its deficiency benefits atherosclerosis progression and may cause endothelial inflammation and dysfunction in coronary artery. There is not any evidences study vitamin D deficiency treatment on non ST-Segment Elevation Myocardial Infarction nor there is any study demonstrating its effect on cardiovascular health through Holick's protocol. Furthermore endothelial function, cardiac work retrieval and inflammation after 8 weeks has not been studied with this protocol yet.

According to current data, the investigators assume by treating this vital and worldwide deficit in our body, doctors can help decrease inflammation, decelerate the atherosclerosis progression and enhance ventricular function after infarction.

Besides all of the recognized risk factors, vitamin D deficiency should be considered a very important and mischievous cardiovascular alarm for the body, which should be treated and maintained through the whole life due to lack of sufficient sunlight exposure and nutrition intake.

In preventive medicine domain, the investigators anticipate by maintaining a high level of this vitamin in the body, cardiovascular events decrease and its burden on society will decline to much extend leading to a higher quality of life and health worldwide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. 30-65 years old patients

2. Hypovitaminosis D (serum 25(OH) Vitamin D< 20 ng/ml)

3. Written and informed consent to participate in this project

4. Non ST-Segment Elevation Myocardial Infarction: any patients with chest pain or any discomfort and suspected MI who referred to our Heart Center Emergency Room without any ST-Segment Elevation (according to J-point) in 12-lead ECG (according to American Heart Association (AHA) guidelines) plus increasing level of serum cardiac Troponin I

Exclusion Criteria:

1. Normal Vitamin D level

2. Body mass index (BMI)>30 kg/m2

3. Do not tend to attend in this study

4. Any life-threatening medical condition

5. Hyperparathyroidism (parathyroid hormone (PTH)>upper normal limit according to lab reference range)

6. Liver failure (any positive past medical history or Aspartate and Alanine aminotransferase (AST and ALT) 2 times more than normal upper limit)

7. Renal Failure (any positive past medical history or Glomerular filtration rate <60 ml/min/1.73 m2 estimated with MDRD formula of Qx calculate application)

8. Any prior history of diagnosed cancer, rheumatologic and immunologic disorders