Clinical trial NCT00376025: Antioxidant Supplementation in Patients With Kashin-Beck Disease
Official title: Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kashin-Beck Disease
Keywords: Kashin-Beck Disease
Kashin-Beck Osteoarthropathy
Lead sponsor: Innovative Humanitarian Solutions
Sponsor class: OTHER
Collaborators: name: University of Houston - Victoria
First posted: 2006-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months
timeFrame: One Year
Secondary outcomes:
measure: Increase in serum selenium concentrations at 6 months
timeFrame: Six Months
Other outcomes:
Locations:
city: Lhasa
country: China
facility: Lhasa Prefecture and surrounding villages
state: Tibet
Study officials:
affiliation: University of Houston - Victoria
name: Richard Gunasekera, Ph.D.
role: STUDY_CHAIR
affiliation: Innovative Humanitarian Solutions
name: Jeff C Cokenour, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovative Humanitarian Solutions
name: Minh Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. doi: 10.1677/joe.1.05971.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. doi: 10.1002/biof.5520190306.
citation: 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