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Antioxidant Supplementation in Patients With Kashin-Beck Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Innovative Humanitarian Solutions.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Houston - Victoria
Information provided by:
Innovative Humanitarian Solutions
ClinicalTrials.gov Identifier:
NCT00376025
First received: September 12, 2006
Last updated: February 12, 2008
Last verified: February 2008
History of Changes
  Purpose

The purpose of this study is to determine whether antioxidant supplementation can have a positive health effect on patients suffering from Kashin-Beck disease.


Condition Intervention Phase
Kashin-Beck Disease
 Dietary Supplement: Biological Antioxidant Supplementation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by Innovative Humanitarian Solutions:

Primary Outcome Measures:
  • Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Biological Antioxidant Supplementation
    Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
Detailed Description:

Current research regarding Kashin-Beck disease, (KBD) have identified dramatic deficiencies of both selenium and iodine in patients with this disease. Initial supplementation of these trace minerals provided no measurable benefit to the affected population. Research conducted by Innovative Humanitarian Solutions, suggests that such deficiencies may not be causal, but markers of an underlying condition of extreme oxidative stress brought on by the improper functioning of the Glutathione Peroxidase enzyme in synthesizing H202 during periods of critical cellular development, primarily in mesenchymal cell development.

The purpose of this trial is to determine the efficacy of antioxidant supplementation in aiding the Glutathione Peroxidase enzyme in its proper function and thereby reducing oxidative stress and enabling the uptake of selenium and iodine which are necessary for proper bone growth and development.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed patients with Kashin-Beck disease

Exclusion Criteria:

  • less than 24 hours from admission to ICU
  • Patients who are moribund
  • Lack of commitment to program
  • Absolute contraindication to enteral nutrients
  • Severe acquired brain injury
  • Pregnant or lactating patients
  • Previous randomization in this study
  • Enrollment in a related interventional study
  • Child's class C liver disease Metastatic cancer with life expectancy < 6 months Seizure disorder requiring anticonvulsant medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376025

Contacts
Contact: Jeff C Cokenour, B.S. 832-863-5690 jeff.cokenour@gmail.com
Contact: Don Heath, B.S. donh@tamh.net

Locations
China, Tibet
Lhasa Prefecture and surrounding villages Recruiting
Lhasa, Tibet, China, 850000
Sub-Investigator: Don Heath            
Sponsors and Collaborators
Innovative Humanitarian Solutions
University of Houston - Victoria
Investigators
Study Chair: Richard Gunasekera, Ph.D. University of Houston - Victoria
Principal Investigator: Jeff C Cokenour, B.S. Innovative Humanitarian Solutions
Principal Investigator: Minh Han, M.D. Innovative Humanitarian Solutions
  More Information

Additional Information:
Innovative Humanitarian Solutions website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Richard S. Gunasekera, Ph.D., Study Chair and P.I., University of Houston - Victoria
ClinicalTrials.gov Identifier: NCT00376025     History of Changes
Other Study ID Numbers: KB001
Study First Received: September 12, 2006
Last Updated: February 12, 2008
Health Authority: China: Ministry of Health
United States: Institutional Review Board

Keywords provided by Innovative Humanitarian Solutions:
Kashin-Beck Disease
Kashin-Beck Osteoarthropathy

Additional relevant MeSH terms:
Kashin-Beck Disease
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013