Antioxidant Supplementation in Patients With Kashin-Beck Disease - Full Text View

Sponsors and Collaborators:	Innovative Humanitarian Solutions University of Houston - Victoria
Information provided by:	Innovative Humanitarian Solutions
ClinicalTrials.gov Identifier:	NCT00376025

Purpose

The purpose of this study is to determine whether antioxidant supplementation can have a positive health effect on patients suffering from Kashin-Beck disease.

Condition	Intervention	Phase
Kashin-Beck Disease	Dietary Supplement: Biological Antioxidant Supplementation	Phase II

MedlinePlus related topics: Antioxidants

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease

Further study details as provided by Innovative Humanitarian Solutions:

Primary Outcome Measures:

Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase in serum selenium concentrations at 6 months [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.

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

Ages Eligible for Study:	9 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376025

Contacts

Contact: Jeff C Cokenour, B.S.	832-863-5690	jeff.cokenour@gmail.com
Contact: Don Heath, B.S.		donh@tamh.net

Locations

China, Tibet
Lhasa Prefecture and surrounding villages	Recruiting
Lhasa, Tibet, China, 850000
Sub-Investigator: Don Heath

Sponsors and Collaborators

Innovative Humanitarian Solutions

University of Houston - Victoria

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

More Information

Innovative Humanitarian Solutions website This link exits the ClinicalTrials.gov site

Publications:

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.

Kohrle J, Jakob F, Contempre B, Dumont JE. Selenium, the thyroid, and the endocrine system. Endocr Rev. 2005 Dec;26(7):944-84. Epub 2005 Sep 20. Review.

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.

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.

Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. Review.

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.

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.

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.

Utiger RD. Kashin-Beck disease--expanding the spectrum of iodine-deficiency disorders. N Engl J Med. 1998 Oct 15;339(16):1156-8. No abstract available.

Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. Review.

Responsible Party:	University of Houston - Victoria ( Richard S. Gunasekera, Ph.D., Study Chair and P.I. )
Study ID Numbers:	KB001
Study First Received:	September 12, 2006
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00376025
Health Authority:	China: Ministry of Health; United States: Institutional Review Board

Keywords provided by Innovative Humanitarian Solutions:

Kashin-Beck Disease
Kashin-Beck Osteoarthropathy

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009