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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00300937
Date of registration: 08/03/2006
Primary sponsor: Teran, Enrique, MD, PhD
Public title: Coenzyme Q10 Supplementation and Development of Preeclampsia
Scientific title: Coenzyme Q10 Supplementation in Pregnant Women as Strategy to Reduce Maternal Morbidity Due to Preeclampsia
Date of first enrolment: July 2004
Target sample size: 235
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00300937
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Ecuador
Contacts
Name:   Enrique Teran, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Biomedical Center - Central University of Ecuador
Key inclusion & exclusion criteria

Inclusion Criteria:

- Primigravidae

- Younger than 25 years old

- No history of disease related to cardiovascular, endocrine, metabolic or reproductive
systems

- To be recruited before than week 20 of gestation

- To sign the Informed Consent form

Exclusion Criteria:

- Voluntary withdrawal

- Poor compliance of visit/treatment



Age minimum: 14 Years
Age maximum: 25 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Preeclampsia
Intervention(s)
Dietary Supplement: Coenzyme Q10
Primary Outcome(s)
Preeclampsia rate in both groups [Time Frame: Delivery]
Secondary Outcome(s)
Newborns weight [Time Frame: Delivery]
Secondary ID(s)
PFN-03-053
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Central University, Ecuador
Ecuadorian Foundation for Science and Technology - FUNDACYT
Jarrow Formulas Inc
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