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

September 12, 2006
February 12, 2008
July 2007
January 2009   (final data collection date for primary outcome measure)
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months
  • Score on FLACC or Word Graphic pain rating scale at end of trial
Complete list of historical versions of study NCT00376025 on ClinicalTrials.gov Archive Site
Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ] [ Designated as safety issue: No ]
Increase in serum selenium concentrations at 6 months
Not Provided
Not Provided
 
Antioxidant Supplementation in Patients With Kashin-Beck Disease
Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Kashin-Beck Disease
Dietary Supplement: Biological Antioxidant Supplementation
Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
9 Years to 18 Years
No
Contact: Jeff C Cokenour, B.S. 832-863-5690 jeff.cokenour@gmail.com
Contact: Don Heath, B.S. donh@tamh.net
China
 
NCT00376025
KB001
Yes
Richard S. Gunasekera, Ph.D., Study Chair and P.I., University of Houston - Victoria
Innovative Humanitarian Solutions
University of Houston - Victoria
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
Innovative Humanitarian Solutions
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP