Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Coenzyme Q10 Supplementation and Development of Preeclampsia

This study has been completed.
Sponsor:
Collaborators:
Ecuadorian Foundation for Science and Technology - FUNDACYT
Central University, Ecuador
Jarrow Formulas Inc
Information provided by:
Teran, Enrique, MD, PhD
ClinicalTrials.gov Identifier:
NCT00300937
First received: March 8, 2006
Last updated: November 21, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   14 Years to 25 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00300937     History of Changes
Other Study ID Numbers: PFN-03-053
Study First Received: March 8, 2006
Last Updated: November 21, 2007
Health Authority: Ecuador: Public Health Ministry

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

ClinicalTrials.gov processed this record on November 27, 2014