Coenzyme Q10 therapy in lithotripsy in patients with renal lithiasis
| ISRCTN | ISRCTN05823740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05823740 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/02/2010
- Registration date
- 19/03/2010
- Last edited
- 19/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julia Carrasco
Scientific
Scientific
Hu Reina Sofia
Servico de Urologia
3ª Planta Edificio de Consultas
Avda Menendez Pidal S/N
Cordoba
14004
Spain
| Phone | +34 629 80 37 51 |
|---|---|
| juliacv83@hotmail.com |
Study information
| Study design | Prospective randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Coenzyme Q10 therapy in lithotripsy in patients with renal lithiasis: a prospective randomised double-blind trial |
| Study acronym | Q10LT |
| Study objectives | 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(s) | Local Ethics Committee of the Reina Sofia Hospital approved in February 2009 |
| Health condition(s) or problem(s) studied | Renal lithiasis |
| Intervention | Coenzyme Q10 is administered (two 30 mg capsules every 8 hours) for 14 days versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Coenzyme Q10 |
| Primary outcome measure | 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 study start date | 01/05/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 112 patients (56 in each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hu Reina Sofia
Cordoba
14004
Spain
14004
Spain
Sponsor information
Association of Urology Research and Development (Asociacion de Urologia y Desarrollo de la Investigacion) (Spain)
Research organisation
Research organisation
Hu Reina Sofia
Servico de Urologia
3ª Planta Edifico de Consultas
Cordoba
14004
Spain
| Phone | +34 629 80 37 51 |
|---|---|
| juliacv83@hotmail.com | |
"ROR" |
https://ror.org/039xbga15 |
Funders
Funder type
Hospital/treatment centre
Hu Reina Sofia Hospital (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
