Antioxidant Supplementation in Pregnant Women (ASIP1)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnant Women Preeclampsia |
Dietary Supplement: micronutrient antioxidant Dietary Supplement: Control |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status |
- Preeclampsia [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]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)
- Cell-free mRNA [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]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))
| Enrollment: | 168 |
| Study Start Date: | June 2001 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
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
Other Name: antioxidant
|
| Placebo Comparator: Control |
Dietary Supplement: Control
supplementation with milk
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Indonesia | |
| Cipto Mangunkusumo National Hospital | |
| Jakarta, Indonesia, 13210 | |
| Study Director: | Noroyono Wibowo, MD, PhD | Dept Obstetrics Gynecology, Indonesia University |
| Principal Investigator: | Yuditiya Purwosunu, MD | Dept Obstetrics Gynecology Indonesia University |
More Information
No publications provided by Showa University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yuditiya Purwosunu, Dept Obstetrics Gynecology, Indonesia University |
| ClinicalTrials.gov Identifier: | NCT01232205 History of Changes |
| Other Study ID Numbers: | asip02 |
| Study First Received: | November 1, 2010 |
| Results First Received: | November 2, 2010 |
| Last Updated: | November 2, 2010 |
| Health Authority: | Indonesia: Departement Kesehatan (Department of Health) |
Keywords provided by Showa University:
|
antioxidant supplementation preeclampsia |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Antioxidants Micronutrients Trace Elements |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013