LithiasisFAGOTRICIANCT05525130
Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.
A study testing Food supplement in people with Lithiasis and Nephrolithiasis, run by Arafarma Group, S.A. at 3 sites in Spain.
Trial summary
The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithiasis, Nephrolithiasis
- What is being tested?
- Food supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 3 sitesSpain
- Study dates
- 22 Apr 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by ESWL, being symptomatic with little probability of spontaneous expulsion.
- Signed informed consent to participate in the clinical study.
Who cannot join
- Lithiasis of more than 20 mm and less than 15 mm for the largest diameter.
- Taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin B6, vitamin D, vitamin A, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals).
- Taking medications that influence urine pH (citrate, bicarbonate, carbonic anhydrase inhibitors, L-methionine, vitamin C, ammonium chloride).
- Taking selective serotonin reuptake inhibitor antidepressant medications.
- Taking anticoagulants and antiaggregants.
- ESWL contraindications: urine infection, active or recurrent; hemorrhagic diathesis; pregnant or lactating patients; others (extreme obesity, arterial aneurysm near the location of the stone, etc.).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Clínico San Cecilio
Granada, 18016
Hospital Universitario Regional de Málaga
Málaga, 29010
Hospital Universitario Virgen de Valme
Seville, 41014
About this study
Official title: Experimental Study of the Administration of a Food Supplement Containing Hydroxycitric Acid Versus Placebo in Patients With Oxalate and Calcium Phosphate Lithiasis in Whom Extracorporeal Shock Wave Lithotripsy is Indicated.
The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself.
It is thought that additional treatments to the ESWL could improve the success rate of ESWL for less favorable stones.
Read more
The components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. Also these components show an inhibitory effect on the growth of calcium phosphate crystals. To sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones.
This is the reason why this experimental study aims to modify the size limit of the stones in the ESWL with adjuvant food supplement.
Read the detailed description
The study treatment will be administered for 10 weeks. First, one dose will be administered every 12 hours for each patient during the 4 weeks prior to ESWL. After ESWL, and for 6 weeks, one dose will be administered every 24 hours.
- Conditions
- Lithiasis, Nephrolithiasis
- Being tested
- Food supplement, Placebo
- Medical subject headings
- Lithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.
PlaceboDietary supplement
Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement | Experimental | Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. Receives: Dietary Supplement: Food supplement |
| Placebo | Placebo comparator | Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the % of reduction of the size (area) of lithiasis through imaging tests.
Measured: 10 weeks after baseline visit
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the number of generated fragments through imaging tests.
Measured: 10 weeks after baseline visit
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the hardness of lithiasis through imaging tests.
Measured: 10 weeks after baseline visit
Secondary outcomes (1)
Rate of morbidities related to the ESWL between both treatment groups.
All episodes of morbidities related to the ESWL will be recorded, whether considered relevant.
Measured: 2 weeks and 6 weeks after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start22 Apr 2020
- Primary completion16 Sep 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Arrabal Martín, Dr, Study chair, Hospital Universitario Clínico San Cecilio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525130
- Sponsor's protocol ID
- ARA-EXP/FAG-2019-03
- Acronym
- FAGOTRICIA
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study of the Administration of a Food Supplement Containing Hydroxycitric Acid Versus Placebo in Patients With Oxalate and Calcium Phosphate Lithiasis in Whom Extracorporeal Shock Wave Lithotripsy is Indicated.
- ClinicalTrials.gov ID
- NCT05525130
- Acronym / sponsor ID
- FAGOTRICIA / ARA-EXP/FAG-2019-03
- Conditions
- Lithiasis, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself.
It is thought that additional treatments to the ESWL could improve the success rate of ESWL for less favorable stones.
The components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. Also these components show an inhibitory effect on the growth of calcium phosphate crystals. To sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones.
This is the reason why this experimental study aims to modify the size limit of the stones in the ESWL with adjuvant food supplement.
Detailed description
The study treatment will be administered for 10 weeks. First, one dose will be administered every 12 hours for each patient during the 4 weeks prior to ESWL. After ESWL, and for 6 weeks, one dose will be administered every 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food supplement | Experimental | Dietary Supplement: Food supplementTwo doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by ESWL, being symptomatic with little probability of spontaneous expulsion.
- Signed informed consent to participate in the clinical study.
Key exclusion criteria (6 listed)
- Lithiasis of more than 20 mm and less than 15 mm for the largest diameter.
- Taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin B6, vitamin D, vitamin A, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals).
- Taking medications that influence urine pH (citrate, bicarbonate, carbonic anhydrase inhibitors, L-methionine, vitamin C, ammonium chloride).
- Taking selective serotonin reuptake inhibitor antidepressant medications.
- Taking anticoagulants and antiaggregants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementFagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions. | Dietary supplement | Food supplement |
| PlaceboPlacebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®. | Dietary supplement | Placebo |
Primary outcome
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.
Time frame: 10 weeks after baseline visit
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the % of reduction of the size (area) of lithiasis through imaging tests.
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.
Time frame: 10 weeks after baseline visit
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the number of generated fragments through imaging tests.
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.
Time frame: 10 weeks after baseline visit
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the hardness of lithiasis through imaging tests.
1 secondary outcome
Rate of morbidities related to the ESWL between both treatment groups.
Time frame: 2 weeks and 6 weeks after ESWL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Arrabal Martín, Dr study chair
Hospital Universitario Clínico San Cecilio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Lithiasis and Nephrolithiasis, run by Arafarma Group, S.A. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups. (time frame: 10 weeks after baseline visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.