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Antioxidant Supplementation in Patients With Kashin-Beck Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376025
Recruitment Status : Unknown
Verified February 2008 by Innovative Humanitarian Solutions.
Recruitment status was:  Recruiting
First Posted : September 14, 2006
Last Update Posted : February 22, 2008
Sponsor:
Collaborator:
University of Houston - Victoria
Information provided by:
Innovative Humanitarian Solutions

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Kashin-Beck Disease Dietary Supplement: Biological Antioxidant Supplementation Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease
Study Start Date : July 2007
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Biological Antioxidant Supplementation
    Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.

Outcome Measures
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Primary Outcome Measures :
  1. Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376025


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

Locations
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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
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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
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Additional Information:

Publications:
Molecular Biology of selenium with its implications for metabolism. Raymond F. Burke, Division of Gastroenterology, division of Medicine and center in molecular toxicology, Vanderbilt University school of medicine, Nashville, Tenn 37232, USA

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Responsible Party: Richard S. Gunasekera, Ph.D., Study Chair and P.I., University of Houston - Victoria
ClinicalTrials.gov Identifier: NCT00376025    
Other Study ID Numbers: KB001
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: February 2008
Keywords provided by Innovative Humanitarian Solutions:
Kashin-Beck Disease
Kashin-Beck Osteoarthropathy
Additional relevant MeSH terms:
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Kashin-Beck Disease
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs