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| Name | Class |
|---|---|
| University of Houston - Victoria | OTHER |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological Antioxidant Supplementation | Dietary Supplement | Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate. |
| Measure | Description | Time Frame |
|---|---|---|
| Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in serum selenium concentrations at 6 months | Six Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff C Cokenour, B.S. | Contact | 832-863-5690 | jeff.cokenour@gmail.com | |
| Don Heath, B.S. | Contact | donh@tamh.net |
| Name | Affiliation | Role |
|---|---|---|
| Richard Gunasekera, Ph.D. | University of Houston - Victoria | Study Chair |
| Jeff C Cokenour, B.S. | Innovative Humanitarian Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lhasa Prefecture and surrounding villages | Recruiting | Lhasa | Tibet | 850000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16484530 | Background | Moreno-Reyes R, Egrise D, Boelaert M, Goldman S, Meuris S. Iodine deficiency mitigates growth retardation and osteopenia in selenium-deficient rats. J Nutr. 2006 Mar;136(3):595-600. doi: 10.1093/jn/136.3.595. | |
| 16174820 | Background | Kohrle J, Jakob F, Contempre B, Dumont JE. Selenium, the thyroid, and the endocrine system. Endocr Rev. 2005 Dec;26(7):944-84. doi: 10.1210/er.2001-0034. Epub 2005 Sep 20. |
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| ID | Term |
|---|---|
| D057767 | Kashin-Beck Disease |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Minh Han, M.D. |
| Innovative Humanitarian Solutions |
| Principal Investigator |
| 15817859 | Background | Xia Y, Hill KE, Byrne DW, Xu J, Burk RF. Effectiveness of selenium supplements in a low-selenium area of China. Am J Clin Nutr. 2005 Apr;81(4):829-34. doi: 10.1093/ajcn/81.4.829. |
| 15795427 | Background | Esworthy RS, Yang L, Frankel PH, Chu FF. Epithelium-specific glutathione peroxidase, Gpx2, is involved in the prevention of intestinal inflammation in selenium-deficient mice. J Nutr. 2005 Apr;135(4):740-5. doi: 10.1093/jn/135.4.740. |
| 15749805 | Background | Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. doi: 10.1677/joe.1.05971. |
| 12816783 | Background | Moreno-Reyes R, Mathieu F, Boelaert M, Begaux F, Suetens C, Rivera MT, Neve J, Perlmutter N, Vanderpas J. Selenium and iodine supplementation of rural Tibetan children affected by Kashin-Beck osteoarthropathy. Am J Clin Nutr. 2003 Jul;78(1):137-44. doi: 10.1093/ajcn/78.1.137. |
| 10591383 | Background | Stamler J, Stamler R, Neaton JD, Wentworth D, Daviglus ML, Garside D, Dyer AR, Liu K, Greenland P. Low risk-factor profile and long-term cardiovascular and noncardiovascular mortality and life expectancy: findings for 5 large cohorts of young adult and middle-aged men and women. JAMA. 1999 Dec 1;282(21):2012-8. doi: 10.1001/jama.282.21.2012. |
| 11172165 | Background | Harris NS, Crawford PB, Yangzom Y, Pinzo L, Gyaltsen P, Hudes M. Nutritional and health status of Tibetan children living at high altitudes. N Engl J Med. 2001 Feb 1;344(5):341-7. doi: 10.1056/NEJM200102013440504. |
| 9770565 | Background | Utiger RD. Kashin-Beck disease--expanding the spectrum of iodine-deficiency disorders. N Engl J Med. 1998 Oct 15;339(16):1156-8. doi: 10.1056/NEJM199810153391611. No abstract available. |
| 14757964 | Background | Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. doi: 10.1002/biof.5520190306. |
| Background | Molecular Biology of selenium with its implications for metabolism. Raymond F. Burke, Division of Gastroenterology, division of Medicine and center in molecular toxicology, Vanderbilt University school of medicine, Nashville, Tenn 37232, USA |