Advertisement

Topics

Coenzyme Q10 Supplementation and Development of Preeclampsia

2014-07-23 21:45:50 | BioPortfolio

Summary

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.

Description

This research will be conducted in collaboration between the Experimental Pharmacology and Cellular Metabolism at the Biomedical Center in the Central University of Ecuador and the Department of Obstetric Pathology in the Gynecology and Obstetrics Hospital "Isidro Ayora" (HGOIA) in Quito, Ecuador. It is proposed a descriptive, prospective, double blind, randomized and placebo controlled experimental study to identify cause-effect rather than effectiveness of the treatment in which, after approval of the Bioethics Committee (COBI) of the Biomedical Center as well as the Bioethics Committee of the HGOIA, each one of the possible women to be included in the study, after a careful and detailed lecture and explanation about the objectives and procedures by one of the researchers will be invited to take a part in it and will be asked to sing the respective inform consent.

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, primigravidae, younger than 25 years old and with no history of diseases related to the cardiovascular, endocrine, metabolic nor reproductive systems, who were currently attending to the outpatients clinic at the HGOIA for pregnancy control before than week 20 of gestation. Those women with positive inclusion criteria and who accepted to participate in the study will be randomized to one of the treatment groups.

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. Women with history of hypertension, currently taken any kind of medication, or that not want to participate in the study will be excluded. 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. These information will be collected into the clinical record of the HGOIA and in a special designated form useful for later data entry in an electronic database (Epi Info V6.04).

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. Plasma aliquots of 500 ul will be frozen at -80°C up to the analysis. During all this process samples will be protected from direct light with aluminum foil and from extreme temperatures with a refrigerated flask. Samples received at the Biomedical Center will be identified only with a code; therefore biochemical analysis will be also performed in a blind fashion. 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. The different bottles for those women will be prepared by a member of the team not related to the clinical control of women, and a careful control of the number of tablets in each bottle will be taken to later on analyze the accomplishment of the treatments. The blind codes will be obtained before the intervention started and will be responsibility of the principal investigator up to the end of the study.

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. In addition, as a part of the study their attention in the HGOIA will be mandatory. Preeclampsia diagnosis will be performed only by clinical researchers and based on a persistent high blood pressure higher than 140/90 mmHg measured two times with the patient rested for at least 10 minutes and with a mercury sphygmomanometer two times (Riester, Germany) and proteinuria higher than 300 mg/24 hours or two crosses in a diskstip with 3-24 hours apart.

Coenzyme Q10 and alpha tocopherol will be measured using a high performance liquid chromatography equipment (HPLC) and the method previously described and validated by our group. In brief, plasma samples will be processed in an HPLC equipped with a reverse phase ODS-C18 column (5 um, 150x4.6 mm) with its respective guard column (5 um, 10x4.6 mm). Mobile phase will be methanol/ethanol (40:60 v/v) previously filtered and with a continuous flow of 1ml/min. The UV detector will be set up to a wavelength of 275 nm. Samples (0.5 ml) will be mixed with 0.5 ml of sodium dodecyl sulphate (SDS) at 20% and 50 ul of CoQ9 solution in ethanol as internal standard. Later will be added 2 ml of a methanol/propanol solution (95:5 v/v) and will be vorterex vigorously by 30 seconds, after that, 5 ml of hexane will be added and vorterex again by 60 seconds. Organic and aqueous solvents will be separated by centrifugation at low speed (1000 g by 5 min). Four and half ml of the organic phase will be transferred to another vial and dissecatted under continuous nitrogen flow and then reconstituted with ethanol. Prepared samples will be immediately analyzed and kept all the time under ice and protected form light. Measurements will be performed in duplicate and average values will be used for the statistical analysis. Intra and inter assay variation coefficients, as well as recover percentage will be calculate to ensure the uniformity of the assays. Also, total cholesterol, as well as, low and high cholesterol lipoproteins will be measured using a spectrophotometer.

Primary endpoint will be the number of preeclampsia cases in each group, and the severity of the disease and quality of the newborn (weight, height, cephalic perimeter and gestational age at born).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Preeclampsia

Intervention

Coenzyme Q10

Location

Hospital Gineco-obstetrico Isidro Ayora
Quito
Ecuador

Status

Completed

Source

Teran, Enrique, MD, PhD

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:45:50-0400

Clinical Trials [192 Associated Clinical Trials listed on BioPortfolio]

Novel Biomarkers of Preeclampsia

This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.

Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer

This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment. Doxorubicin is a lifesaving breast cancer treatment....

Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The treatment p...

Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

The clinical syndrome of PSP responds poorly to all available forms of therapy used in Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has b...

Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia. The secondary objective of the study is to analyze t...

PubMed Articles [306 Associated PubMed Articles listed on BioPortfolio]

LncRNA CCAT1 promotes the progression of preeclampsia by regulating CDK4.

Preeclampsia is one of the leading causes of maternal and perinatal deaths. This study mainly explored the mechanism of long non-coding RNA (lncRNA) CCAT1 expression in the placenta of preeclampsia pa...

A tag SNP in syncytin-2 3-UTR significantly correlates with the risk of severe preeclampsia.

Preeclampsia is a disease that frequently complicates pregnancy and poses a serious threat to maternal and fetal health. The causes and pathogenic mechanisms of preeclampsia are poorly defined. Geneti...

Hypermethylation of delta-like homolog 1/maternally expressed gene 3 loci in human umbilical veins: insights into offspring vascular dysfunction born after preeclampsia.

Increasing epidemiological studies have confirmed the association between maternal preeclampsia and elevated blood pressure in their offspring. Though case-control or cohort studies have demonstrated ...

Aspirin for Evidence-Based Preeclampsia Prevention trial: effect of aspirin on length of stay in the neonatal intensive care unit.

Preeclampsia is a major pregnancy complication with adverse short- and long-term implications for both the mother and baby. Screening for preeclampsia at 11-13 weeks' gestation by a combination of mat...

Maternal allergy as an isolated risk factor for early-onset preeclampsia: An epidemiological study.

Immunological mechanisms underlying the development of preeclampsia are well known, but no association to allergy has yet been demonstrated. The aim of this study was to assess the correlation between...

Medical and Biotech [MESH] Definitions

S-Acyl coenzyme A. Fatty acid coenzyme A derivatives that are involved in the biosynthesis and oxidation of fatty acids as well as in ceramide formation.

A coenzyme A derivative which plays a key role in the fatty acid synthesis in the cytoplasmic and microsomal systems.

A ferredoxin-containing enzyme that catalyzes the COENZYME A-dependent oxidative decarboxylation of PYRUVATE to acetyl-COENZYME A and CARBON DIOXIDE.

Natural compounds containing alternating carbonyl and methylene groups (beta-polyketones), bioenergenetically derived from repeated condensation of acetyl coenzyme A via malonyl coenzyme A, in a process similar to fatty acid synthesis.

Enzymes which transfer coenzyme A moieties from acyl- or acetyl-CoA to various carboxylic acceptors forming a thiol ester. Enzymes in this group are instrumental in ketone body metabolism and utilization of acetoacetate in mitochondria. EC 2.8.3.

More From BioPortfolio on "Coenzyme Q10 Supplementation and Development of Preeclampsia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial