Condition category
Urological and Genital Diseases
Date applied
20/02/2010
Date assigned
19/03/2010
Last edited
19/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Carrasco

ORCID ID

Contact details

Hu Reina Sofia
Servico de Urologia
3ª Planta Edificio de Consultas
Avda Menendez Pidal S/N
Cordoba
14004
Spain
+34 629 80 37 51
juliacv83@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Coenzyme Q10 therapy in lithotripsy in patients with renal lithiasis: a prospective randomised double-blind trial

Acronym

Q10LT

Study hypothesis

Urinary tract lithiasis is associated with renal damage secondary to the appearance of inflammatory changes and imbalances in hormone regulation of angiotensin II axis, which finally lead to the development of fibrosis. Today it is accepted that the treatment of initial choice for most cases of urolithiasis is the application of extracorporeal shockwave lithotripsy that by shock wave emission causes fragmentation of the calculus, allowing their elimination by the excretory way. Associated to the injuries by lithotripsy appears inflammatory phenomena and vasoactive hormonal. In both cases, the final common mediator lies in oxidative imbalance.

Therefore, the use of drugs with antioxidant capacity, such as co-Q10 might reduce kidney damage associated with the application of lithotripsy for patients with urinary tract lithiasis.

Ethics approval

Local Ethics Committee of the Reina Sofia Hospital approved in February 2009

Study design

Prospective randomised controlled double-blind trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Renal lithiasis

Intervention

Coenzyme Q10 is administered (two 30 mg capsules every 8 hours) for 14 days versus placebo.

Intervention type

Drug

Phase

Phase IV

Drug names

Coenzyme Q10

Primary outcome measures

Determination of glomerular filtration rate (MDRD), measured in June 2010 and September 2010

Secondary outcome measures

Measured in June 2010 and September 2010:
1. Biochemical markers of oxidative stress:
1.1. MDA
1.2. Glutation
1.3. SOD
1.4. Catalase

Overall trial start date

01/05/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged 25 to 65 years (either sex) with urinary tract lithiasis
2. Candidates to applying lithotripsy
3. Lithiasis located in the renal pelvis and/or calyx

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 112 patients (56 in each group)

Participant exclusion criteria

1. Patients undergoing lithotripsy at the time of initiating the study
2. Patients with previously diagnosed renal lithotripsy
3. Patients treated with calcium channel blockers
4. Complications of lithotripsy that determine the need for further intervention in the study period
5. Taking antiplatelet 3 days before extracorporeal shock-wave lithotripsy (ESWL) session
6. Controlled clotting disorders
7. Complete distal obstruction to the calculation to be treated
8. Unrecovery kidney
9. Allergy to the components of medications
10. Inability to understand or psychosocial misadjustment
11. Refusal to sign informed consent

Recruitment start date

01/05/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Hu Reina Sofia
Cordoba
14004
Spain

Sponsor information

Organisation

Association of Urology Research and Development (Asociacion de Urologia y Desarrollo de la Investigacion) (Spain)

Sponsor details

Hu Reina Sofia
Servico de Urologia
3ª Planta Edifico de Consultas
Cordoba
14004
Spain
+34 629 80 37 51
juliacv83@hotmail.com

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hu Reina Sofia Hospital (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes