Objective: The aim of this study is to determine the effects of zinc supplementation on biomarkers of inflammation and oxitative and pregnancy outcomes in gestational diabetes. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 50 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either zinc supplement (intervention group: n=25) or placebo (control group: n=25). Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (December 5, 2014-May 10, 2015). Outcomes: High-sensitivity C-reactive protein (hs-CRP), nitric oxide (NO), plasma total antioxidant capacity (TAC) and total glutathione (GSH) at study baseline and end-of-trial will be measured. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505095623N42
Registration date:2015-05-22, 1394/03/01
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-05-22, 1394/03/01
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-10-27, 1393/08/05
Expected recruitment end date
2014-11-26, 1393/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on biomarkers of inflammation, stress oxidative and pregnancy outcomes in women with gestational diabetes
Public title
Effect of zinc in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with preeclampsia; complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.