Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy. (FAGOTRICIA)

February 22, 2023 updated by: Arafarma Group, S.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18016
        • Hospital Universitario Clínico San Cecilio
      • Málaga, Spain, 29010
        • Hospital Universitario Regional de Málaga
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Food supplement
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Dietary supplement: Food supplement
FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.
Placebo Comparator: Placebo
Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.
Dietary supplement: Placebo
Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks after baseline visit
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.
10 weeks after baseline visit
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.
10 weeks after baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of morbidities related to the ESWL between both treatment groups.
Time Frame: 2 weeks and 6 weeks after ESWL
All episodes of morbidities related to the ESWL will be recorded, whether considered relevant.
2 weeks and 6 weeks after ESWL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arafarma Group, S.A.

Investigators

  • Study Chair: Miguel Arrabal Martín, Dr, Hospital Universitario Clínico San Cecilio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2020

Primary Completion (Actual)

September 16, 2022

Study Completion (Actual)

October 5, 2022

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARA-EXP/FAG-2019-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe