ArthritisPhase 1NCT01421160
Regulating Urine pH Levels to Alleviate Chronic Joint Pain
A Phase 1 study testing sodium citrate and citric acid in people with Arthritis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
This study aims to determine the causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Arthritis
- What is being tested?
- sodium citrate and citric acid
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of joint pain of perceived inflammatory and non-inflammatory origin for more than six months. More specifically:
- Subjects with osteoarthritis (OA) of the knee will be preferred for inclusion in this study.
- Subjects with other joint pain history will be included pursuant on approval from Dr. Miller or Dr. Pema.
- Age 21 to 80 years old and otherwise in good health (excluding the joint pain).
- Able to understand and comply with the assigned urine alkalinization instructions.
- Has a working and reliable telephone number for continued contact as necessary during the study.
Show all 9Show fewer
- Ability to obtain X-rays of the affected joint. Imaging of the painful joint will be necessary at the beginning of the study for baseline considerations; if images from the last 6 months are available, no new imaging would be necessary.
- Ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) or can obtain documentation of recent lab tests that have been taken within one month prior to enrollment.
- Ability to obtain lab tests at 3 and 6 months during participation in the study.
Who cannot join
- Presence of joint pain with known joint osseous changes.
- Pregnant or lactating women will not be enrolled in the study.
- Positive medical history of:
- Diabetes
- Neuropathies
- Gout
Show all 18Show fewer
- Psychiatric diseases and conditions, including anxiety, depression, PTSD, distress
- Psychosocial abnormalities
- Dementia or other memory disturbances
- Alcoholism or substance abuse
- Renal failure and/or abnormal renal function (kidney disease or dysfunction). Specifically, Creatinine (Creat) values that are over 1.2mg/dL and Urea Nitrogen (BUN) values that are over 22mg/dL are considered abnormal.
- No history of cardiovascular disease, intestinal angina or arrhythmias
- No history of sodium restrictions
- Pt. should not be taking medications which produce pain such as angiotensin converting enzyme (ACE) inhibitors and Statins (Lisinopril, Quinapril, Ramipril)
- Does not have reliable telephone communication.
- Does not have the ability to obtain an X-ray and does not have the ability to obtain documentation of a recent X-ray within the last six months.
- Does not have the ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) and does not have the ability to obtain documentation of recent lab tests that have been taken within one month prior to enrollment.
- Does not have the ability to obtain lab tests at 3 and 6 months during participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine
El Paso, Texas, 79905
About this study
Official title: A Pilot Study to Assess the Effects of Regulating Urine pH Levels for Alleviating Chronic Joint Pain
This study aims to determine the causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment regimen.
Read the detailed description
STUDY SYNOPSIS / Literature Review Inflammation is a local immune response to injury, infection and foreign molecules. Notwithstanding the provoking cause, inflammation is thought to have evolved as an adaptive response for restoring tissue homeostasis. The local inflammatory response causes acidosis and pain has been associated with induced acidosis of various origins - diet, injury, exercise, stress, medications, disease state or aging.
Inflammatory and degenerative joint diseases are major causes of chronic pain. In general, inflammatory causes (e.g. rheumatoid arthritis, RA) are more common in younger individuals, while degenerative causes (e.g. osteoarthritis, OA) are more often seen in the elderly [Schaible et al, 2009]. Pain perception is extremely complex and a perceived connection has been noted between the level of pain felt by individuals and bodily fluid hydrogen ion concentration, i.e. pH; oral water-soluble alkaline components containing K, Ca, Mg and Cl salts have been used for reducing bodily fluid and tissue acid concentrations. Urine pH is now considered to reflect the bodily acid-base balance and is directly related to the dietary acid-base load [Welch et al, 2008].
Currently, potassium citrate (Kcit, 45-60 mEq daily) has been widely used in urology for treatment of patients with uric acid and cystine stones [Sterrett et al, 2008; Spivacow et al, 2010]. Aside from the use of Kcit in the treatment of kidney stones, there have been isolated reports about the anti-inflammatory and hypoalgesic systems effects of Kcit. Alkalinization by diet alone has also been effective for removing uric acid from the body, though its effects on urine pH levels are weaker [Kanbara, Hakoda \& Seyama, 2010]. It is considered that alkalinization of urine reflects body fluid alkalinization. This has the perceived effects of increased bone density, improved muscle function, and a speculative decrease in insulin resistance [Pizzorno, Frassetto \& Katzinger, 2010].
Research Project Question/Theme The investigators aim to determine causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment regimen.
Project Design:
Subjects will be recruited from local physician's practices, primarily at TTUHSC clinics, by the Principal Investigator and the Co-Investigators. Subjects who report a presence of joint pain for more than six months, and meet the inclusion/exclusion criteria, will be eligible for participation.
Any Adverse Events (AEs) will be monitored by the Principal Investigator and Co-Investigators, and reported by the Study Coordinator to the IRB.
Subjects for the study will be identified by the Principal Investigator and Co-Investigators from local TTUHSC clinics.
After the subject agrees to participate and informed consent has been given, the study coordinator will explain the study procedures and baseline measurements will be assessed using diagnostic imaging and lab testing. All subjects will be asked to obtain and/or provide a copy of recent X-rays or an MRI of the affected joint and lab tests (CBC, liver and kidney panels). Images and tests must be recent and taken within the past 6 months of enrollment in the study.
After the baseline measurements have been established, instructions on the urine alkalinization treatment regimen will be distributed to the subject and treatment solution will be obtained. This treatment will vary from person to person and is easily modified.
Subjects will measure, report, and take the treatment for 6 months.
While on the treatment, all subjects will be asked to report and/or measure the following values on a daily basis:
- Report when and how much treatment was taken that day
- Measure urine pH levels daily at 10 A.M. using a pH strip
- Rate their pain 3X daily using a modified pain rating scale
- Report daily food and beverage intake
- Visit the physician investigator for monthly a follow-up visit to review the pain ratings and pH values noted during the past month
Analysis:
Using the SAS System, the investigators calculated the minimum number of enrolled subjects that is required to achieve statistical results is 21. The investigators estimated that a minimum number of 16 subjects must complete the study in order to achieve sufficient, statistically powerful results. In order to ensure successful completion of the statistical data analysis, the investigators decided to enroll twice the minimum number of subjects required (16x2) and will enroll a total of 32 subjects.
- Conditions
- Arthritis
- Being tested
- sodium citrate and citric acid
- Keywords
- Chronic, Inflammatory, Joint, Pain
- Medical subject headings
- Arthritis, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium citrate and citric acidDrug
Also called Cytra-2
sodium citrate and citric acid equivalent to 1 mEq/ml bicarbonate (usual dose 10-30 mls/day diluted with water)
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-and post test pain rating
At the beginning of the study, during office visits, and at the end of the study, subjects will be asked to visually and numerically rate their pain levels.
Measured: Six months
Change in Urine pH from baseline
Subject's daily self-report of this measure will be provided to study investigator at each office visit.
Measured: Six months
Changes in lab results (routine blood work) from baseline
Assessed at the beginning, middle (3 months) and end of the six month study.
Measured: Six months.
Change in amount of alkalization medication taken daily
Subject's daily self-report of this measure will be provided to study investigator at each office visit.
Measured: Six months
Secondary outcomes (1)
Daily food and beverage intake
Subject's daily self-report of this measure will be provided to the study investigator at each office visit.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Why it stopped: PI left the institution prior to any data being collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Miller, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Dennis W Miller, MD, Principal investigator, Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421160
- Sponsor's protocol ID
- citrate1
- Status last verified
- May 2017
- First submitted
- 20 Jul 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Schaible HG, Richter F, Ebersberger A, Boettger MK, Vanegas H, Natura G, Vazquez E, Segond von Banchet G. Joint pain. Exp Brain Res. 2009 Jun;196(1):153-62. doi: 10.1007/s00221-009-1782-9. Epub 2009 Apr 11.
PubMed 19363606Goldring MB, Goldring SR. Osteoarthritis. J Cell Physiol. 2007 Dec;213(3):626-34. doi: 10.1002/jcp.21258.
PubMed 17786965Devchand PR, Keller H, Peters JM, Vazquez M, Gonzalez FJ, Wahli W. The PPARalpha-leukotriene B4 pathway to inflammation control. Nature. 1996 Nov 7;384(6604):39-43. doi: 10.1038/384039a0.
PubMed 8900274Gurol et al, US Patent 2007/0218126 A1. Compositions and methods for reducing inflammation and pain associated with acidosis (7p.).
Sterrett SP, Penniston KL, Wolf JS Jr, Nakada SY. Acetazolamide is an effective adjunct for urinary alkalization in patients with uric acid and cystine stone formation recalcitrant to potassium citrate. Urology. 2008 Aug;72(2):278-81. doi: 10.1016/j.urology.2008.04.003. Epub 2008 Jun 4.
PubMed 18533229Pizzorno J, Frassetto LA, Katzinger J. Diet-induced acidosis: is it real and clinically relevant? Br J Nutr. 2010 Apr;103(8):1185-94. doi: 10.1017/S0007114509993047. Epub 2009 Dec 15.
PubMed 20003625Kiwull-Schone H, Kiwull P, Manz F, Kalhoff H. Food composition and acid-base balance: alimentary alkali depletion and acid load in herbivores. J Nutr. 2008 Feb;138(2):431S-434S. doi: 10.1093/jn/138.2.431S.
PubMed 18203917Kanbara A, Hakoda M, Seyama I. Urine alkalization facilitates uric acid excretion. Nutr J. 2010 Oct 19;9:45. doi: 10.1186/1475-2891-9-45.
PubMed 20955624Welch AA, Mulligan A, Bingham SA, Khaw KT. Urine pH is an indicator of dietary acid-base load, fruit and vegetables and meat intakes: results from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk population study. Br J Nutr. 2008 Jun;99(6):1335-43. doi: 10.1017/S0007114507862350. Epub 2007 Nov 28.
PubMed 18042305Medzhitov R. Origin and physiological roles of inflammation. Nature. 2008 Jul 24;454(7203):428-35. doi: 10.1038/nature07201.
PubMed 18650913Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.
PubMed 19837031Aras B, Kalfazade N, Tugcu V, Kemahli E, Ozbay B, Polat H, Tasci AI. Can lemon juice be an alternative to potassium citrate in the treatment of urinary calcium stones in patients with hypocitraturia? A prospective randomized study. Urol Res. 2008 Dec;36(6):313-7. doi: 10.1007/s00240-008-0152-6. Epub 2008 Oct 23.
PubMed 18946667McNally MA, Pyzik PL, Rubenstein JE, Hamdy RF, Kossoff EH. Empiric use of potassium citrate reduces kidney-stone incidence with the ketogenic diet. Pediatrics. 2009 Aug;124(2):e300-4. doi: 10.1542/peds.2009-0217. Epub 2009 Jul 13.
PubMed 19596731Whitson PA, Pietrzyk RA, Jones JA, Nelman-Gonzalez M, Hudson EK, Sams CF. Effect of potassium citrate therapy on the risk of renal stone formation during spaceflight. J Urol. 2009 Nov;182(5):2490-6. doi: 10.1016/j.juro.2009.07.010. Epub 2009 Sep 17.
PubMed 19765769Spivacow FR, Negri AL, Polonsky A, Del Valle EE. Long-term treatment of renal lithiasis with potassium citrate. Urology. 2010 Dec;76(6):1346-9. doi: 10.1016/j.urology.2010.02.029.
PubMed 20399488
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Regulating Urine pH Levels for Alleviating Chronic Joint Pain
- ClinicalTrials.gov ID
- NCT01421160
- Acronym / sponsor ID
- citrate1
- Conditions
- Arthritis
- Keywords
- Chronic, Inflammatory, Joint, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution prior to any data being collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment regimen.
Detailed description
STUDY SYNOPSIS / Literature Review Inflammation is a local immune response to injury, infection and foreign molecules. Notwithstanding the provoking cause, inflammation is thought to have evolved as an adaptive response for restoring tissue homeostasis. The local inflammatory response causes acidosis and pain has been associated with induced acidosis of various origins - diet, injury, exercise, stress, medications, disease state or aging.
Inflammatory and degenerative joint diseases are major causes of chronic pain. In general, inflammatory causes (e.g. rheumatoid arthritis, RA) are more common in younger individuals, while degenerative causes (e.g. osteoarthritis, OA) are more often seen in the elderly [Schaible et al, 2009]. Pain perception is extremely complex and a perceived connection has been noted between the level of pain felt by individuals and bodily fluid hydrogen ion concentration, i.e. pH; oral water-soluble alkaline components containing K, Ca, Mg and Cl salts have been used for reducing bodily fluid and tissue acid concentrations. Urine pH is now considered to reflect the bodily acid-base balance and is directly related to the dietary acid-base load [Welch et al, 2008].
Currently, potassium citrate (Kcit, 45-60 mEq daily) has been widely used in urology for treatment of patients with uric acid and cystine stones [Sterrett et al, 2008; Spivacow et al, 2010]. Aside from the use of Kcit in the treatment of kidney stones, there have been isolated reports about the anti-inflammatory and hypoalgesic systems effects of Kcit. Alkalinization by diet alone has also been effective for removing uric acid from the body, though its effects on urine pH levels are weaker [Kanbara, Hakoda \& Seyama, 2010]. It is considered that alkalinization of urine reflects body fluid alkalinization. This has the perceived effects of increased bone density, improved muscle function, and a speculative decrease in insulin resistance [Pizzorno, Frassetto \& Katzinger, 2010].
Research Project Question/Theme The investigators aim to determine causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment regimen.
Project Design:
Subjects will be recruited from local physician's practices, primarily at TTUHSC clinics, by the Principal Investigator and the Co-Investigators. Subjects who report a presence of joint pain for more than six months, and meet the inclusion/exclusion criteria, will be eligible for participation.
Any Adverse Events (AEs) will be monitored by the Principal Investigator and Co-Investigators, and reported by the Study Coordinator to the IRB.
Subjects for the study will be identified by the Principal Investigator and Co-Investigators from local TTUHSC clinics.
After the subject agrees to participate and informed consent has been given, the study coordinator will explain the study procedures and baseline measurements will be assessed using diagnostic imaging and lab testing. All subjects will be asked to obtain and/or provide a copy of recent X-rays or an MRI of the affected joint and lab tests (CBC, liver and kidney panels). Images and tests must be recent and taken within the past 6 months of enrollment in the study.
After the baseline measurements have been established, instructions on the urine alkalinization treatment regimen will be distributed to the subject and treatment solution will be obtained. This treatment will vary from person to person and is easily modified.
Subjects will measure, report, and take the treatment for 6 months.
While on the treatment, all subjects will be asked to report and/or measure the following values on a daily basis:
- Report when and how much treatment was taken that day
- Measure urine pH levels daily at 10 A.M. using a pH strip
- Rate their pain 3X daily using a modified pain rating scale
- Report daily food and beverage intake
- Visit the physician investigator for monthly a follow-up visit to review the pain ratings and pH values noted during the past month
Analysis:
Using the SAS System, the investigators calculated the minimum number of enrolled subjects that is required to achieve statistical results is 21. The investigators estimated that a minimum number of 16 subjects must complete the study in order to achieve sufficient, statistically powerful results. In order to ensure successful completion of the statistical data analysis, the investigators decided to enroll twice the minimum number of subjects required (16x2) and will enroll a total of 32 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of joint pain of perceived inflammatory and non-inflammatory origin for more than six months. More specifically:
- Age 21 to 80 years old and otherwise in good health (excluding the joint pain).
- Able to understand and comply with the assigned urine alkalinization instructions.
- Has a working and reliable telephone number for continued contact as necessary during the study.
- Ability to obtain X-rays of the affected joint. Imaging of the painful joint will be necessary at the beginning of the study for baseline considerations; if images from the last 6 months are available, no new imaging would be necessary.
Key exclusion criteria (18 listed)
- Presence of joint pain with known joint osseous changes.
- Pregnant or lactating women will not be enrolled in the study.
- Positive medical history of:
- Does not have reliable telephone communication.
- Does not have the ability to obtain an X-ray and does not have the ability to obtain documentation of a recent X-ray within the last six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium citrate and citric acidAlso: Cytra-2sodium citrate and citric acid equivalent to 1 mEq/ml bicarbonate (usual dose 10-30 mls/day diluted with water) | Drug | – |
Primary outcome
Pre-and post test pain rating
Time frame: Six months
At the beginning of the study, during office visits, and at the end of the study, subjects will be asked to visually and numerically rate their pain levels.
Change in Urine pH from baseline
Time frame: Six months
Subject's daily self-report of this measure will be provided to study investigator at each office visit.
Changes in lab results (routine blood work) from baseline
Time frame: Six months.
Assessed at the beginning, middle (3 months) and end of the six month study.
Change in amount of alkalization medication taken daily
Time frame: Six months
Subject's daily self-report of this measure will be provided to study investigator at each office visit.
1 secondary outcome
Daily food and beverage intake
Time frame: Six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 19363606Schaible HG, Richter F, Ebersberger A, Boettger MK, Vanegas H, Natura G, Vazquez E, Segond von Banchet G. Joint pain. Exp Brain Res. 2009 Jun;196(1):153-62. doi: 10.1007/s00221-009-1782-9. Epub 2009 Apr 11.
- Background: PubMed 17786965Goldring MB, Goldring SR. Osteoarthritis. J Cell Physiol. 2007 Dec;213(3):626-34. doi: 10.1002/jcp.21258.
- Background: PubMed 8900274Devchand PR, Keller H, Peters JM, Vazquez M, Gonzalez FJ, Wahli W. The PPARalpha-leukotriene B4 pathway to inflammation control. Nature. 1996 Nov 7;384(6604):39-43. doi: 10.1038/384039a0.
- BackgroundGurol et al, US Patent 2007/0218126 A1. Compositions and methods for reducing inflammation and pain associated with acidosis (7p.).
- Background: PubMed 18533229Sterrett SP, Penniston KL, Wolf JS Jr, Nakada SY. Acetazolamide is an effective adjunct for urinary alkalization in patients with uric acid and cystine stone formation recalcitrant to potassium citrate. Urology. 2008 Aug;72(2):278-81. doi: 10.1016/j.urology.2008.04.003. Epub 2008 Jun 4.
- Background: PubMed 20003625Pizzorno J, Frassetto LA, Katzinger J. Diet-induced acidosis: is it real and clinically relevant? Br J Nutr. 2010 Apr;103(8):1185-94. doi: 10.1017/S0007114509993047. Epub 2009 Dec 15.
- Background: PubMed 18203917Kiwull-Schone H, Kiwull P, Manz F, Kalhoff H. Food composition and acid-base balance: alimentary alkali depletion and acid load in herbivores. J Nutr. 2008 Feb;138(2):431S-434S. doi: 10.1093/jn/138.2.431S.
- Background: PubMed 20955624Kanbara A, Hakoda M, Seyama I. Urine alkalization facilitates uric acid excretion. Nutr J. 2010 Oct 19;9:45. doi: 10.1186/1475-2891-9-45.
- Background: PubMed 18042305Welch AA, Mulligan A, Bingham SA, Khaw KT. Urine pH is an indicator of dietary acid-base load, fruit and vegetables and meat intakes: results from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk population study. Br J Nutr. 2008 Jun;99(6):1335-43. doi: 10.1017/S0007114507862350. Epub 2007 Nov 28.
- Background: PubMed 18650913Medzhitov R. Origin and physiological roles of inflammation. Nature. 2008 Jul 24;454(7203):428-35. doi: 10.1038/nature07201.
- Background: PubMed 19837031Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.
- Background: PubMed 18946667Aras B, Kalfazade N, Tugcu V, Kemahli E, Ozbay B, Polat H, Tasci AI. Can lemon juice be an alternative to potassium citrate in the treatment of urinary calcium stones in patients with hypocitraturia? A prospective randomized study. Urol Res. 2008 Dec;36(6):313-7. doi: 10.1007/s00240-008-0152-6. Epub 2008 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis W Miller, MD principal investigator
Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sodium citrate and citric acid in people with Arthritis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-and post test pain rating (time frame: Six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421160, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.