Regulating Urine pH Levels to Alleviate Chronic Joint Pain

NCT01421160 | Withdrawn Phase 1

• 1 other identifier: citrate1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 regimen.

Conditions

Arthritis

Keywords

Chronic; Inflammatory; Joint; Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Six months

Secondary Outcomes (1)

• Daily food and beverage intake

  Six months

Interventions

sodium citrate and citric acid DRUG

sodium citrate and citric acid equivalent to 1 mEq/ml bicarbonate (usual dose 10-30 mls/day diluted with water)

Also known as: Cytra-2

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of joint pain of perceived inflammatory and non-inflammatory origin for more than six months. More specifically:
• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine

El Paso, Texas, 79905, United States

Location

Related Publications (17)

• 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.

  PMID: 19363606 BACKGROUND

• Goldring MB, Goldring SR. Osteoarthritis. J Cell Physiol. 2007 Dec;213(3):626-34. doi: 10.1002/jcp.21258.

  PMID: 17786965 BACKGROUND

• Devchand 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.

  PMID: 8900274 BACKGROUND

• Gurol et al, US Patent 2007/0218126 A1. Compositions and methods for reducing inflammation and pain associated with acidosis (7p.).

  BACKGROUND

• 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.

  PMID: 18533229 BACKGROUND

• Pizzorno 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.

  PMID: 20003625 BACKGROUND

• Kiwull-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.

  PMID: 18203917 BACKGROUND

• Kanbara 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.

  PMID: 20955624 BACKGROUND

• Welch 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.

  PMID: 18042305 BACKGROUND

• Medzhitov R. Origin and physiological roles of inflammation. Nature. 2008 Jul 24;454(7203):428-35. doi: 10.1038/nature07201.

  PMID: 18650913 BACKGROUND

• Basbaum 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.

  PMID: 19837031 BACKGROUND

• Aras 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.

  PMID: 18946667 BACKGROUND

• McNally 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.

  PMID: 19596731 BACKGROUND

• Whitson 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.

  PMID: 19765769 BACKGROUND

• Spivacow 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.

  PMID: 20399488 BACKGROUND

• Iakovenko EP, Agafonova NA, Pokhal'skaia OIu, Kolganova AV, Nazarbekova RS, Ivanov AN, Davletshina IV, Popova EV, Prianishnikova AS, Ovchinnikova NI, Iakovenko AV, Aldiiarova MA, D'iachkoava AV, Gioeva IZ. [The use of bismuth tripotassium dicitrate (De-Nol), a promising line of pathogenetic therapy for irritated bowel syndrome with diarrhea]. Klin Med (Mosk). 2008;86(10):47-52. Russian.

  PMID: 19069460 BACKGROUND

• Balkowiec-Iskra E. [The role of immune system in inflammatory pain pathophysiology]. Pol Merkur Lekarski. 2010 Dec;29(174):395-9. Polish.

  PMID: 21298993 BACKGROUND

MeSH Terms

Conditions

Arthritis; Bronchiolitis Obliterans Syndrome; Pain

Interventions

Sodium Citrate; Citric Acid; Citrates

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dennis W Miller, MD

  Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: August 22, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

US (1)