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

Nephrolithiasis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525130
• Other study ID #: ARA-EXP/FAG-2019-03
• Status: Completed
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: February 2023
• Source: Arafarma Group, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 5, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Kidney Calculi
• Lithiasis
• Nephrolithiasis

Intervention

Dietary Supplement:
• Food supplement
FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.
• Placebo
Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

Locations

Country	Name	City	State
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Regional de Málaga	Málaga
Spain	Hospital Universitario Virgen de Valme	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Arafarma Group, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 weeks after baseline visit
Primary	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.	10 weeks after baseline visit
Primary	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.	10 weeks after baseline visit
Secondary	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.	2 weeks and 6 weeks after ESWL