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Antioxidant Supplementation in Pregnant Women (ASIP1)

Primary Purpose

Pregnant Women, Preeclampsia

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
micronutrient antioxidant
Control
Sponsored by
Showa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnant Women focused on measuring antioxidant supplementation, preeclampsia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Cipto Mangunkusumo National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

micronutrient antioxidant

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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))

Full Information

First Posted
November 1, 2010
Last Updated
November 2, 2010
Sponsor
Showa University
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT01232205
Brief Title
Antioxidant Supplementation in Pregnant Women
Acronym
ASIP1
Official Title
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Showa University
Collaborators
Indonesia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women, Preeclampsia
Keywords
antioxidant supplementation, preeclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
micronutrient antioxidant
Arm Type
Active Comparator
Arm Description
Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
micronutrient antioxidant
Other Intervention Name(s)
antioxidant
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
supplementation with milk
Primary Outcome Measure Information:
Title
Preeclampsia
Description
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)
Time Frame
40 weeks
Title
Preeclampsia
Description
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)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Cell-free mRNA
Description
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))
Time Frame
40 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noroyono Wibowo, MD, PhD
Organizational Affiliation
Dept Obstetrics Gynecology, Indonesia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuditiya Purwosunu, MD
Organizational Affiliation
Dept Obstetrics Gynecology Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
ZIP/Postal Code
13210
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22563751
Citation
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.
Results Reference
derived

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Antioxidant Supplementation in Pregnant Women

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