Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 55 for:    severe preeclampsia AND gestational

Antioxidant Supplementation in Pregnant Women (ASIP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Indonesia University
Information provided by:
Showa University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Conditions Pregnant Women
Preeclampsia
Interventions Dietary Supplement: micronutrient antioxidant
Dietary Supplement: Control
Enrollment 168
Recruitment Details Recruitment started in June 2001 and completed in December 2009, Department of Obstetrics and Gynaecology, University of Indonesia, at Cipto Mangunkusumo National Hospital
Pre-assignment Details There were 110 (65.4 percent) eligible subjects from 168 pregnant women, because of ferric reducing ability of plasma (FRAP) level measured
Arm/Group Title Micronutrient Antioxidant Control
Hide Arm/Group Description Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium [Not Specified]
Period Title: Overall Study
Started 52 58
Completed 49 55
Not Completed 3 3
Arm/Group Title Micronutrient Antioxidant Control Total
Hide Arm/Group Description Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 52 58 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 58 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
58
 100.0%
110
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 58 participants 110 participants
28.1  (5.08) 29.7  (5.07) 28.9  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 58 participants 110 participants
Female
52
 100.0%
58
 100.0%
110
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Indonesia Number Analyzed 52 participants 58 participants 110 participants
52 58 110
1.Primary Outcome
Title Preeclampsia
Time Frame 40 weeks
Outcome Measure Data Not Reported
2.Primary Outcome
Title Preeclampsia
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronutrient Antioxidant Control
Hide Arm/Group Description:
Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
[Not Specified]
Overall Number of Participants Analyzed 52 58
Measure Type: Number
Unit of Measure: participants
1 8
3.Secondary Outcome
Title Cell-free mRNA
Hide 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
Outcome Measure Data Not Reported
Time Frame nine months
Adverse Event Reporting Description monthly questionare
 
Arm/Group Title Micronutrient Antioxidant Control
Hide Arm/Group Description Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium [Not Specified]
All-Cause Mortality
Micronutrient Antioxidant Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Micronutrient Antioxidant Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Micronutrient Antioxidant Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yuditiya Purwosunu
Organization: Dept Obstetrics Gynecology Indonesia University
Phone: +44 753 870 6897
EMail: yudi@med.showa-u.ac.jp
Layout table for additonal information
Responsible Party: Yuditiya Purwosunu, Dept Obstetrics Gynecology, Indonesia University
ClinicalTrials.gov Identifier: NCT01232205     History of Changes
Other Study ID Numbers: asip02
First Submitted: November 1, 2010
First Posted: November 2, 2010
Results First Submitted: November 2, 2010
Results First Posted: December 2, 2010
Last Update Posted: December 2, 2010