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Antioxidant Supplementation in Pregnant Women

NCT ID: NCT01232205

Last Updated: 2010-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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

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Pregnant Women Preeclampsia

Keywords

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antioxidant supplementation preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

micronutrient antioxidant

Intervention Type DIETARY_SUPPLEMENT

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

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

supplementation with milk

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Control

supplementation with milk

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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antioxidant

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role collaborator

Showa University

OTHER

Sponsor Role lead

Responsible Party

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Dept Obstetrics Gynecology, Indonesia University

Principal Investigators

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Noroyono Wibowo, MD, PhD

Role: STUDY_DIRECTOR

Dept Obstetrics Gynecology, Indonesia University

Yuditiya Purwosunu, MD

Role: PRINCIPAL_INVESTIGATOR

Dept Obstetrics Gynecology Indonesia University

Locations

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Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

References

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Wibowo N, Purwosunu Y, Sekizawa A, Farina A, Idriansyah L, Fitriana I. Antioxidant supplementation in pregnant women with low antioxidant status. J Obstet Gynaecol Res. 2012 Sep;38(9):1152-61. doi: 10.1111/j.1447-0756.2012.01855.x. Epub 2012 May 8.

Reference Type DERIVED
PMID: 22563751 (View on PubMed)

Other Identifiers

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asip02

Identifier Type: -

Identifier Source: org_study_id