Kashin-Beck Disease
Conditions
Keywords
Kashin-Beck Disease, Kashin-Beck Osteoarthropathy
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.
Interventions
DIETARY_SUPPLEMENTBiological Antioxidant Supplementation
Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
Sponsors
University of Houston - Victoria
Innovative Humanitarian Solutions
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months | One Year |
Secondary
| Measure | Time frame |
|---|---|
| Increase in serum selenium concentrations at 6 months | Six Months |
Countries
China
Contacts
Primary ContactJeff C Cokenour, B.S.
Backup ContactDon Heath, B.S.
Outcome results
None listed