Antioxidant Supplementation in Pregnant Women

Preeclampsia Clinical Trial

— ASIP1  

Official title:

Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232205
• Other study ID #: asip02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 1, 2010
• Last updated: November 2, 2010
• Start date: June 2001
• Est. completion date: March 2010

Study information

• Verified date: December 2009
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Pregnant Women

Intervention

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
• Control
supplementation with milk

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Showa University	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia	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)	40 weeks	No
Primary	Preeclampsia	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)	9 months	No
Secondary	Cell-free mRNA	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))	40 weeks	No