Back to resultsStudy of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy. (FAGOTRICIA)
Primary Purpose
Lithiasis, Nephrolithiasis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Food supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lithiasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
Sites / Locations
- Hospital Universitario Clínico San Cecilio
- Hospital Universitario Regional de Málaga
- Hospital Universitario Virgen de Valme
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Food supplement
Placebo
Arm Description
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05525130
Brief Title
Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.
Acronym
FAGOTRICIA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arafarma Group, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lithiasis, Nephrolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food supplement
Arm Type
Experimental
Arm Description
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Food supplement
Intervention Description
FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.
Primary Outcome Measure Information:
Title
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as reduction of the size (area) of lithiasis between both treatment groups.
Description
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.
Time Frame
10 weeks after baseline visit
Title
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as number of generated fragments between both treatment groups.
Description
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the number of generated fragments through imaging tests.
Time Frame
10 weeks after baseline visit
Title
Efficacy of extracorporeal shock wave lithotripsy (ESWL) measured as the hardness of lithiasis between both treatment groups.
Description
To assess the level of fragmentation of lithiasis which is treated with ESWL by measuring the hardness of lithiasis through imaging tests.
Time Frame
10 weeks after baseline visit
Secondary Outcome Measure Information:
Title
Rate of morbidities related to the ESWL between both treatment groups.
Description
All episodes of morbidities related to the ESWL will be recorded, whether considered relevant.
Time Frame
2 weeks and 6 weeks after ESWL
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Arrabal Martín, Dr
Organizational Affiliation
Hospital Universitario Clínico San Cecilio
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.
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