Antioxidant Supplementation in Pregnant Women (ASIP1)

• ClinicalTrials.gov Identifier: NCT01232205
• Recruitment Status: Completed
• First Posted: November 2, 2010
• Results First Posted: December 2, 2010
• Last Update Posted: December 2, 2010
• Sponsor: Showa University
• Collaborator: Indonesia University
• Information provided by: Showa University

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.

Condition or disease	Intervention/treatment	Phase
Pregnant Women; Preeclampsia	Dietary Supplement: micronutrient antioxidant; Dietary Supplement: Control	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
• Study Start Date: June 2001
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Preeclampsia [ Time Frame: 40 weeks ]
   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)
2. Preeclampsia [ Time Frame: 9 months ]
   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 :

1. Cell-free mRNA [ Time Frame: 40 weeks ]
   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))

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yuditiya Purwosunu, Dept Obstetrics Gynecology, Indonesia University
• ClinicalTrials.gov Identifier: NCT01232205 History of Changes
• Other Study ID Numbers: asip02
• First Posted: November 2, 2010
• Results First Posted: December 2, 2010
• Last Update Posted: December 2, 2010
• Last Verified: December 2009

Keywords provided by Showa University:

antioxidant supplementation; preeclampsia

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Trace Elements; Antioxidants; Micronutrients; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Nutrients; Growth Substances