Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 12, 2006
First Posted Date  ICMJE September 14, 2006
Last Update Posted Date February 22, 2008
Study Start Date  ICMJE July 2007
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2006)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2007)
Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2006)
Increase in serum selenium concentrations at 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antioxidant Supplementation in Patients With Kashin-Beck Disease
Official Title  ICMJE Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Kashin-Beck Disease
Intervention  ICMJE Dietary Supplement: Biological Antioxidant Supplementation
Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2008)
300
Original Enrollment  ICMJE
 (submitted: September 13, 2006)
200
Estimated Study Completion Date  ICMJE April 2009
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376025
Other Study ID Numbers  ICMJE KB001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard S. Gunasekera, Ph.D., Study Chair and P.I., University of Houston - Victoria
Study Sponsor  ICMJE Innovative Humanitarian Solutions
Collaborators  ICMJE University of Houston - Victoria
Investigators  ICMJE
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
PRS Account Innovative Humanitarian Solutions
Verification Date February 2008

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