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

Objective: The aim of this study is to determine the effects of combined omega-3 fatty acid and vitamin E supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with breast cystic fibrosis.

Study design: Parallel double-blind randomized controlled clinical trial.

Population and sample size: 56 breast cystic fibrosis eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.

Inclusion criteria: Patients with breast cystic fibrosis according to mammography criteria aged 30 to 55 years. Exclusion criteria: Pregnant women, patients with metabolic disorders including thyroid dysfunction, diabetes or impaired glucose tolerance.

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.

Outcomes: High-sensitivity C-reactive protein and nitric oxide (primary outcomes). Glucose homeostasis parameters, lipid profiles, biomarkers of oxidative stress (secondry outcomes).

Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.

Kashan University of Medical Sciences

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.

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.