NCT01232205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1 month until next milestone

Results Posted

Study results publicly available

December 2, 2010

Completed
Last Updated

December 2, 2010

Status Verified

December 1, 2009

Enrollment Period

8.5 years

First QC Date

November 1, 2010

Results QC Date

November 2, 2010

Last Update Submit

November 2, 2010

Conditions

Pregnant WomenPreeclampsia

Keywords

antioxidant supplementationpreeclampsia

Outcome Measures

Primary Outcomes (2)

  • 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)

    40 weeks

  • 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)

    9 months

Secondary Outcomes (1)

  • Cell-free mRNA

    40 weeks

Study Arms (2)

micronutrient antioxidant

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR
Dietary Supplement: Control

Interventions

micronutrient antioxidantDIETARY_SUPPLEMENT

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

Also known as: antioxidant
micronutrient antioxidant
ControlDIETARY_SUPPLEMENT

supplementation with milk

Control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with 8-12 weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, 13210, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 22563751DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Results Point of Contact

Title
Yuditiya Purwosunu
Organization
Dept Obstetrics Gynecology Indonesia University
yudi@med.showa-u.ac.jp
+44 753 870 6897

Study Officials

  • Noroyono Wibowo, MD, PhD

    Dept Obstetrics Gynecology, Indonesia University

    STUDY DIRECTOR

  • Yuditiya Purwosunu, MD

    Dept Obstetrics Gynecology Indonesia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

June 1, 2001

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

December 2, 2010

Results First Posted

December 2, 2010

Record last verified: 2009-12

Locations

ID(1)