Regulating Urine pH Levels to Alleviate Chronic Joint Pain

This study has been withdrawn prior to enrollment.
(PI left the institution prior to any data being collected)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01421160
First received: July 20, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Arthritis
Drug: sodium citrate and citric acid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Effects of Regulating Urine pH Levels for Alleviating Chronic Joint Pain

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Pre-and post test pain rating [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Subject's daily self-report of this measure will be provided to study investigator at each office visit.


Secondary Outcome Measures:
  • Daily food and beverage intake [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Sugject's daily self-report of this measure will be provided to the study investigator at each office visit.


Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sodium citrate and citric acid
    sodium citrate and citric acid equivalent to 1 mEq/ml bicarbonate (usual dose 10-30 mls/day diluted with water)
    Other Name: Cytra-2
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age 21 to 80 years old and otherwise in good health (excluding the joint pain).
  3. Able to understand and comply with the assigned urine alkalinization instructions.
  4. Has a working and reliable telephone number for continued contact as necessary during the study.
  5. 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.
  6. 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.
  7. Ability to obtain lab tests at 3 and 6 months during participation in the study.

Exclusion Criteria:

  1. Presence of joint pain with known joint osseous changes.
  2. Pregnant or lactating women will not be enrolled in the study.
  3. 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)
  4. Does not have reliable telephone communication.
  5. 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.
  6. 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.
  7. Does not have the ability to obtain lab tests at 3 and 6 months during participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421160

Locations
United States, Texas
Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Dennis W Miller, MD Department of Anesthesiology; Texas Tech University Health Sciences Center; Paul L. Foster School of Medicine
  More Information

Publications:
Goldring MB & Goldring SR. Osteoarthritis. J Cell Physiol (2007) 213:626-634.
Spivacow FR, Negri AL, Polonsky A, & Del Valle EE. Long-term treatment of renal lithiasis with potassium citrate. Urology (2010) 76:1346-1349.
Balkowiec-Iskra E. The role of immune system in inflammatory pain pathophysiology]. Article in Polish. Pol Merkur Lekarski (2010) 29:395-399.

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01421160     History of Changes
Other Study ID Numbers: citrate1
Study First Received: July 20, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Chronic
Inflammatory
Joint
Pain

Additional relevant MeSH terms:
Citric Acid
Anticoagulants
Chelating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014