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Coenzyme Q10 Supplementation and Development of Preeclampsia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300937
First Posted: March 10, 2006
Last Update Posted: November 26, 2007
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.
Collaborators:
Ecuadorian Foundation for Science and Technology - FUNDACYT
Central University, Ecuador
Jarrow Formulas Inc
Information provided by:
Teran, Enrique, MD, PhD
  Purpose

As preeclampsia is a disease specially affecting young and primiparous women, and due to the fact that we found previously in several studies a prevalence of 12%, to ensure a confidence of 95% and a power of 80%, it is necessary to include a total of 190 women (95 in each arm), therefore it is planned to recluse a total of 200 pregnant women currently attending to the outpatients clinic at the HGOIA for pregnancy control before than week 20 of gestation.

From each one of those women the clinical research team will obtain an obstetric, anthropometric and clinical record following the current regulations of the Ecuadorian Public Health Ministry. All women included will be under a detailed prenatal control every 4 weeks from week 20 of pregnancy, this will include gestational age, weight, umbilical perimeter, uterine altitude, fetal cardiac frequency and maternal blood pressure.

In addition, in each schedule visit an urine test will be done (to discard proteinuria), also a venous blood sample (10 ml) in heparinized tubes will be taken and immediately transported to the Biomedical Center for centrifugation and plasma isolation. During week 20, all women will be assigned (using a randomized numbers table) to one of the following groups: a) intervention group, that will received two capsules of 100 mg of coenzyme Q10 twice daily up to delivery; or b) control group, that will receive two capsules of the correspondent placebo twice daily up to delivery. Both, active and placebo capsules will be manufactured by the same provider (Jarrow Formulas, Los Angeles, CA, USA) to guarantee that weight, size, odor and color are similar.

Absolutely all women participating in the study will know all contact information of the clinical team and will be allowed to request medical care as frequent as they needed, independently of establish obstetrical controls. Preeclampsia diagnosis will be performed only by clinical researchers and based on a persistent high blood pressure higher than 140/90 mmHg and proteinuria higher than 300 mg/24 hours.

Coenzyme Q10 will be measured using a high performance liquid chromatography equipment (HPLC) and the method previously described and validated by our group.

The hypothesis is that in the group receiving CoQ10 supplementation will be less cases of preeclampsia compared to placebo.


Condition Intervention Phase
Preeclampsia Dietary Supplement: Coenzyme Q10 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Coenzyme Q10 Supplementation in Pregnant Women as Strategy to Reduce Maternal Morbidity Due to Preeclampsia

Resource links provided by NLM:


Further study details as provided by Teran, Enrique, MD, PhD:

Primary Outcome Measures:
  • Preeclampsia rate in both groups [ Time Frame: Delivery ]

Secondary Outcome Measures:
  • Newborns weight [ Time Frame: Delivery ]

Enrollment: 235
Study Start Date: July 2004
Study Completion Date: September 2006
Arms Assigned Interventions
Experimental: A Dietary Supplement: Coenzyme Q10
100 mg oral BID starting at week 20 until delivery

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300937


Locations
Ecuador
Hospital Gineco-obstetrico Isidro Ayora
Quito, Ecuador
Sponsors and Collaborators
Teran, Enrique, MD, PhD
Ecuadorian Foundation for Science and Technology - FUNDACYT
Central University, Ecuador
Jarrow Formulas Inc
Investigators
Study Director: Enrique Teran, MD, PhD Biomedical Center - Central University of Ecuador
  More Information

ClinicalTrials.gov Identifier: NCT00300937     History of Changes
Other Study ID Numbers: PFN-03-053
First Submitted: March 8, 2006
First Posted: March 10, 2006
Last Update Posted: November 26, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins