Antioxidant Supplementation in Pregnant Women

Phase 2

Completed

• Conditions: Pregnant Women; Preeclampsia
• Interventions: Dietary Supplement: micronutrient antioxidant; Dietary Supplement: Control

• Registration Number: NCT01232205
• Lead Sponsor: Showa University

Brief 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.

Study Timeline

• Study Start: 2001-06
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Results First Submitted: 2010-11-02
• Results First Submitted QC: 2010-11-02
• Last Update Submitted: 2010-11-02
• Results First Posted: 2010-12-02
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micronutrient antioxidant	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
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Preeclampsia	9 months	Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)

Secondary Outcome Measures

Name	Time	Method
Cell-free mRNA	40 weeks	Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia