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Dietary Supplement

Hydroxycitrate for Kidney Stones

Q: Does this research include any individuals younger than 75 years of age?

Adhering to the protocol of this clinical trial, only those aged 21-99 can participate.

Q: What potential hazards are associated with Super CitriMax; OHCit-low dose for individuals participating in the trial?

A score of 3 was assigned to Super CitriMax; OHCit-low dose, due to it being a Phase 4 trial and thus having an established record for safety.

Q: Can I become part of the research for this medical experiment?

Those hoping to participate in this research trial must have a diagnosed case of kidney stones and be between the ages 21-99. Approximately 25 individuals will be accepted for enrollment.

Q: Are there any available openings for this clinical experiment?

Affirmative. The clinical trial is still enrolling patients, as evidenced by its presence on clinicaltrials.gov and the data updated on October 11th 2023. 25 people are expected to be recruited from a single location for this study.

Q: What is the cap on participants for this clinical experiment?

Affirmative. Data hosted on clinicaltrials.gov declares that this research project, which was first posted on October 11th 2023, is recruiting patients now. Approximately 25 subjects need to be recruited from 1 centre of care.

Phase 4

Recruiting

Led By NAIM M MAALOUF

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calcium Phosphate stone formers

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 week of treatment

Awards & highlights

Study Summary

This trial tests if a molecule related to citrate can stop recurring kidney stone formation.

Who is the study for?

This trial is for people who form calcium phosphate kidney stones. It's not suitable for pregnant individuals, those with low potassium levels, frequent urinary infections, chronic diarrhea, poor kidney function (eGFR < 45), or a history of overactive parathyroid glands.Check my eligibility

What is being tested?

The study is testing hydroxycitrate (OHCit) in two different doses to see if it can prevent new kidney stones from forming. Participants will also receive either Potassium Citrate or a placebo as part of the treatment comparison.See study design

What are the potential side effects?

Possible side effects may include gastrointestinal discomfort such as upset stomach or diarrhea and changes in blood potassium levels which could affect heart rhythm and muscle function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I form calcium phosphate kidney stones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 week of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1 week of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 week of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Formation product (FP) for Calcium Phosphate

Secondary outcome measures

Calcium Phosphate supersaturation

Crystal growth of Calcium Phosphate

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Super CitriMax; OHCit-standard doseExperimental Treatment1 Intervention

Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d

Group II: Super CitriMax; OHCit-low doseExperimental Treatment1 Intervention

Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d

Group III: Potassium Citrate (Urocit®-K)Active Control1 Intervention

Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d

Group IV: PlaceboPlacebo Group1 Intervention

Placebo 3 tablets twice daily Total Daily Dose: None

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,710 Total Patients Enrolled

5 Trials studying Kidney Stones

652 Patients Enrolled for Kidney Stones

NAIM M MAALOUFPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include any individuals younger than 75 years of age?

"Adhering to the protocol of this clinical trial, only those aged 21-99 can participate."

Answered by AI

What potential hazards are associated with Super CitriMax; OHCit-low dose for individuals participating in the trial?

"A score of 3 was assigned to Super CitriMax; OHCit-low dose, due to it being a Phase 4 trial and thus having an established record for safety."

Answered by AI

Can I become part of the research for this medical experiment?

"Those hoping to participate in this research trial must have a diagnosed case of kidney stones and be between the ages 21-99. Approximately 25 individuals will be accepted for enrollment."

Answered by AI

Are there any available openings for this clinical experiment?

"Affirmative. The clinical trial is still enrolling patients, as evidenced by its presence on clinicaltrials.gov and the data updated on October 11th 2023. 25 people are expected to be recruited from a single location for this study."

Answered by AI

What is the cap on participants for this clinical experiment?

"Affirmative. Data hosted on clinicaltrials.gov declares that this research project, which was first posted on October 11th 2023, is recruiting patients now. Approximately 25 subjects need to be recruited from 1 centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

Naim Maalouf 2023. "Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003348.

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