| June 26, 2013 |
summary |
Objective: This study is to determine the effects of multivitamin, multivitamin-mineral and probiotic Gaz supplementation on pregnancy outcomes. Study design: Randomized double-blind controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women, primigravida, aged 18-40 year old who were carrying singleton pregnancy at their second and third trimester will be included in this study. Multiparous women as well as those with hypertension, gestational diabetes mellitus (GDM), complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 140 pregnant women of eligible and referred to Naghavi clinic in Kashan, in the study will be selected. Individuals will be divided to 4 groups (2 groups intervention and 2 groups control). Intervention: Subjects will be assigned to receive either multivitamin-mineral supplements and probiotic Gaz (intervention groups) or multivitamin supplements and normal Gaz (control groups). Fasting blood samples will be taken at baseline and after 20-wk intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and End Date of Intervention: 20 weeks (June 21, 2012-November 21, 2012). Outcomes: Baseline and End-of-trial serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides levels, fasting plasma glucose (FPG), serum calcium, iron, zinc levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
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