Antioxidant Supplementation in Patients With Kashin-Beck Disease
Recruitment status was Recruiting
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| First Received Date ICMJE | September 12, 2006 | ||||||||||||
| Last Updated Date | February 12, 2008 | ||||||||||||
| Start Date ICMJE | July 2007 | ||||||||||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00376025 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE |
Increase in serum selenium concentrations at 6 months | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 2 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| 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. |
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| Study Arm (s) | Not Provided | ||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||||||
| Estimated Completion Date | April 2009 | ||||||||||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 9 Years to 18 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00376025 | ||||||||||||
| Other Study ID Numbers ICMJE | KB001 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| 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 |
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| Information Provided By | Innovative Humanitarian Solutions | ||||||||||||
| Verification Date | February 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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