Antioxidant Supplementation in Pregnant Women (ASIP1)

This study has been completed.
Sponsor:
Collaborator:
Indonesia University
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT01232205
First received: November 1, 2010
Last updated: November 2, 2010
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by Showa University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232205

Locations
Indonesia
Cipto Mangunkusumo National Hospital
Jakarta, Indonesia, 13210
Sponsors and Collaborators
Showa University
Indonesia University
Investigators
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 August 18, 2014