NCT01232205

Antioxidant Supplementation in Pregnant Women

Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Showa University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.

Detailed description

Preeclampsia remains one of leading causes of maternal and perinatal mortality and morbidity. Despite intensive research, the cause of preeclampsia has not been established. One of the theories is exaggeration of systemic inflammatory that might induce reactive oxygen species (ROS). It has been proposed that pregnancy will progress uneventfully if adequate antioxidant exists to buffer ROS. The ROS can induce endothelial dysfunction which leads to clinical symptoms of hypertension and proteinuria in preeclampsia. Several large randomized clinical trials of antioxidant supplementation have concluded that there were no benefits of antioxidants supplementation for prevention of preeclampsia. However, there is limited information about benefits of antioxidants in women with low antioxidant status at early gestation that deprived of the antioxidant most. Our aim, therefore, in this study was to assess whether early supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium lowers the risk of preeclampsia in women with low antioxidant status at early gestation.

Conditions

• Pregnant Women
• Preeclampsia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	micronutrient antioxidant	Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
DIETARY_SUPPLEMENT	Control	supplementation with milk

Timeline

• Start date: 2001-06-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2010-11-02
• Last updated: 2010-12-02
• Results posted: 2010-12-02

Locations

1 site across 1 country: Indonesia