Antioxidant Supplementation in Pregnant Women (ASIP1)

Showa University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Preeclampsia; Pregnant Women

Treatments: Dietary Supplement: micronutrient antioxidant; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01232205

asip02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pregnant women with 8-12 weeks of gestation

Exclusion criteria

• known multiple pregnancy
• known fetal anomaly
• known thrombophilia
• known infections and mola hydatidosa
• chronic renal failure
• uncontrolled hypertension
• known placental abnormalities
• documented uterine bleeding within a week of screening
• uterine malformation
• history of medical and metabolic complication such as heart disease or diabetes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups, including a placebo group

micronutrient antioxidant

Active Comparator group

Description:

Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium

Treatment:

Dietary Supplement: micronutrient antioxidant

Control

Placebo Comparator group

Treatment:

Dietary Supplement: Control