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IRCT2017090133941N15 IRCT 2017-11-01 Kashan University of Medical Sciences Effect of combined omega-3 and vitamin D supplementation in treatment of coronary heart disease Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in type 2 diabetic patients with coronary heart disease 2017-11-01 anticipated 74 Complete https://irct.ir/trial/26057 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 and vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinics affiliated with Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded. 3 Coronary Heart Disease. Intervention 1: Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Subjects aged 45-85 years Diagnosed with type 2 diabetes and coronary heart disease Vitamin D-deficient 45 years 85 years Both Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months Experiencing an acute myocardial infarction or cardiac surgery within the past 3 months Renal or hepatic disorder I25.9 Chronic ischaemic heart disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally. Mean left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography. Maximum left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography. Mean right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography. Maximum right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography. Insulin. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Calculation using HOMA formula. Total cholesterol. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. Hs-CRP. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2017-10-12 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)