Antioxidant Supplementation in Patients With Kashin-Beck Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease

Conditions
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Kashin-Beck Disease

Intervention / Treatment
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* Dietary Supplement: Biological Antioxidant Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Biological Antioxidant Supplementation|Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in serum selenium concentrations at 6 months |  | Six Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kashin-Beck Disease, Kashin-Beck Osteoarthropathy