Antioxidant Supplementation in Patients With Kashin-Beck Disease
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|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
|Condition or disease||Intervention/treatment||Phase|
|Kashin-Beck Disease||Dietary Supplement: Biological Antioxidant Supplementation||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
- Dietary Supplement: Biological Antioxidant Supplementation
Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
- Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ]
- Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ]
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
|Contact: Jeff C Cokenour, B.S.||firstname.lastname@example.org|
|Contact: Don Heath, B.S.||email@example.com|
|Lhasa Prefecture and surrounding villages||Recruiting|
|Lhasa, Tibet, China, 850000|
|Sub-Investigator: Don Heath|
|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|