The effect of vitamin D deficiency treatment on lipid profile in ischemic heart diseases: a double blinded randomized clinical trial

The effect of vitamin D deficiency treatment on lipid profile in ischemic heart diseases Determination and comparison of mean triglyceride, total cholesterol, HDL, LDL serum levels before and two months after treatment in both groups

Randomized clinical trial, Double blind, Parallel groups, Randomised using Randomized block design, 66 samples divided in 2 groups

Patients suspected to acute coronary syndrome who are transferred to the emergency room of Isfahan Chamran Hospital, including ischemic heart disease criteria and vitamin D deficiency are entered the study and a personal consent is given. Lipid profile tests will be done initially and patients are divided into two groups: recipients of pearls containing the drug and placebo. Patients receive one pill each week for two months. Then, the mentioned parameters are measured again and their information is recorded. Study is double blinded including both patients and investigators.

Inclusion criteria: Vitamin D deficiency ( <30 ng/ml ) Age: 40 to 65 years Ischemic heart disease : including acute coronary syndrome , stable angina Excluding criteria: Having coronary artery bypass criteria Any life-threatening underlying disease Getting any vitamin supplements

vitamin D deficiency is treated by receiving 50,000 units of vitamin D pearls per week, for up to 2 months and receiving a placebo by the control group similar to the treated group. The control group is given medication for vitamin D deficiency after the study.

Triglyceride, Total cholesterol, HDL, LDL serum levels after getting vitamin D supplement

The patients were allocated into intervention or control group using block randomization method to keep an even randomization ratio of (1:1). If the patient had inclusion criteria and did not excluded from the study according to above mentioned protocol, the random number generating software was used to determine their designated group. Numbers were between 0-9. If the number was even, the letter "A" was wrote at the top of their checklist by the examining physician, and if the number was odd, the letter "B" was used. Then, the next patient had to be assigned to the opposite group. This process repeated for the upcoming patients and continued until we reached our estimated sample size. After completing the study and before starting the data analysis process, the encrypted letters will be revealed by the pharmaceutical company.

Double blinded including both participants and investigators.

IPD collected for the primary outcome measure only

starting 6 months after publication

for people working in academic institutions

any analysis

email addresses

After receiving the e-mail and determining the required data and analyzes on which the data is to be performed and with the consent of the project manager and research assistant The information is provided to the applicant.