- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00376025
Antioxidant Supplementation in Patients With Kashin-Beck Disease
Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jeff C Cokenour, B.S.
- Phone Number: 832-863-5690
- Email: jeff.cokenour@gmail.com
Study Contact Backup
- Name: Don Heath, B.S.
- Email: donh@tamh.net
Study Locations
-
-
Tibet
-
Lhasa, Tibet, China, 850000
- Recruiting
- Lhasa Prefecture and surrounding villages
-
Sub-Investigator:
- Don Heath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months
Time Frame: One Year
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in serum selenium concentrations at 6 months
Time Frame: Six Months
|
Six Months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. doi: 10.1677/joe.1.05971.
- 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.
- 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.
- 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.
- 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.
- Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. doi: 10.1002/biof.5520190306.
- 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
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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