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

NCT05525130 | Completed

• 1 other identifier: ARA-EXP/FAG-2019-03
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Lithiasis; Nephrolithiasis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Rate of morbidities related to the ESWL between both treatment groups.

  2 weeks and 6 weeks after ESWL

Study Arms (2)

Food supplement

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.

Dietary Supplement: Placebo

Interventions

Food supplement DIETARY_SUPPLEMENT

FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.

Food supplement

Placebo DIETARY_SUPPLEMENT

Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (3)

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Lithiasis; Nephrolithiasis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Miguel Arrabal Martín, Dr

  Hospital Universitario Clínico San Cecilio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: September 1, 2022
• Study Start: April 22, 2020
• Primary Completion: September 16, 2022
• Study Completion: October 5, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

ES (3)