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

NCT03405207 | Unknown Phase 2

• 1 other identifier: Isfahan Vitamin D Non-ST-MI
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Non-ST Elevation Myocardial Infarction (nSTEMI); Inflammation; Coronary Artery Disease With Myocardial Infarction

Outcome Measures

Primary Outcomes (6)

• endothelial function(1) change from baseline

  E-Selectin of blood

  change from baseline at 8th weeks after infarction

• endothelial function(2) change from baseline

  fibroblast growth factor 21 of blood

  change from baseline at 8th weeks after infarction

• endothelial function(3) change from baseline

  fibroblast growth factor 23 of blood

  change from baseline at 8th weeks after infarction

• endothelial function(4) change from baseline

  vascular cell adhesion molecule 1 of blood

  change from baseline at 8th weeks after infarction

• endothelial function(5) change from baseline

  inter-cellular cell adhesion molecule 1 of blood

  change from baseline at 8th weeks after infarction

• endothelial function(6) change from baseline

  with flow mediated dilation (FMD)

  change from baseline at 8th weeks after infarction

Secondary Outcomes (10)

• inflammation state(1) changes from baseline

  change from baseline at 8th weeks after infarction

• ventricular function(1) changes from baseline

  change from baseline at 8th weeks after infarction

• inflammation state(2) changes from baseline

  change from baseline at 8th weeks after infarction

• inflammation state(3) changes from baseline

  change from baseline at 8th weeks after infarction

• inflammation state(4) changes from baseline

  change from baseline at 8th weeks after infarction

Study Arms (2)

active drug receiving group

ACTIVE COMPARATOR

the drug is vitamin D3 50000 UNT oral capsule prescribing under Holick's protocol, which is every week for 8 weeks then every month for long life

Drug: Vitamin D3 50000 UNT Oral Capsule

placebo receiving group

PLACEBO COMPARATOR

the same as active comparator unless the drug is the identical placebo oral capsule

Drug: Placebo oral capsule

Interventions

Vitamin D3 50000 UNT Oral Capsule DRUG

Holick's protocol of treating vitamin D deficiency lasting for 8 weeks

Also known as: active drug

active drug receiving group

Placebo oral capsule DRUG

identical as active drug providing by pharmaceutical company unless it is placebo

Also known as: placebo

placebo receiving group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old patients
• Hypovitaminosis D (serum 25(OH) Vitamin D\< 20 ng/ml)
• Written and informed consent to participate in this project
• 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

You may not qualify if:

• Normal Vitamin D level
• Body mass index (BMI)\>30 kg/m2
• Do not tend to attend in this study
• Any life-threatening medical condition
• Hyperparathyroidism (parathyroid hormone (PTH)\>upper normal limit according to lab reference range)
• Liver failure (any positive past medical history or Aspartate and Alanine aminotransferase (AST and ALT) 2 times more than normal upper limit)
• 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)
• Any prior history of diagnosed cancer, rheumatologic and immunologic disorders

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Cardiovascular Rehabilitation Research Center

Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Non-ST Elevated Myocardial Infarction; Inflammation; Coronary Artery Disease, Autosomal Dominant, 1

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• masoumeh sadeghi, M.D.

  Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

masoumeh sadeghi, M.D.

CONTACT

00989134091776; sadeghimasoumeh@gmail.com

erfan sheikhbahaei, student

CONTACT

00989132080913; erfan.shikhbahaei@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Masoumeh Sadeghi

Model Details: we have 2 groups entitled active drug receiver and placebo receiver and patients will randomly allocated between these two groups at first and continue until finishing the study.

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 23, 2018
• Study Start: May 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: August 1, 2019
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)