Clinical trial of the effect of combined omega-3 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles and pregnancy outcomes in patients with gestational diabetes

Objective: The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles and pregnancy outcomes in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 120 patients with gestational diabetes of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined omega-3 fatty acids or vitamin D (n=30), omega-3 fatty acids (n=30), vitamin D supplements (n=30) and placebo (n=30). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Inflammatory factors (primary outcomes), and oxidative stress factors and pregnancy outcomes will be quantified at study baseline and at the end of the trial.

Vice chancellor for research, Ardabil University of Medical Sciences