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IRCT201510315623N55 IRCT 2015-11-20 Vice chancellor for research, Kashan University of Medical Sciences Effects of supplementation in the treatment of breast cystic fibrosis Effects of combined omega-3 fatty acid and vitamin E supplementation compared with the placebo on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with breast cystic fibrosis 2015-09-29 anticipated 56 Complete https://irct.ir/trial/6085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly allocated into two treatment groups to take either supplements (n = 28) or placebo (n = 28). 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, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will allocate the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the 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 Breast cystic fibrosis. Intervention 1: Intervention group: Omega-3 fatty acid and vitamin E capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), 1000 mg omega-3 fatty acid and 400 mg vitamin E, daily for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), daily for 12 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
Bolvare Ghotbe Ravandi, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 2999 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with breast cystic fibrosis according to mammography criteria Aged 30 to 55 years 30 years 55 years Female Pregnant women Patients with metabolic disorders including thyroid dysfunction, diabetes or impaired glucose tolerance N60.0 Solitary cyst of breast Treatment - Drugs Treatment - Drugs Intervention group: Omega-3 fatty acid and vitamin E capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), 1000 mg omega-3 fatty acid and 400 mg vitamin E, daily for 12 weeks orally. Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), daily for 12 weeks orally. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. VLDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Vice chancellor for research, Kashan University of Medical Sciences Approved 2015-09-28 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)