Antioxidant Supplementation in Patients With Kashin-Beck Disease

Sponsor

Innovative Humanitarian Solutions (Other)

Overall Status

Unknown status

CT.gov ID

NCT00376025

Collaborator

University of Houston - Victoria (Other)

300

Enrollment

Location

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kashin-Beck Disease	Dietary Supplement: Biological Antioxidant Supplementation	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Anticipated Primary Completion Date :

Jan 1, 2009

Anticipated Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months [One Year]

Secondary Outcome Measures

Increase in serum selenium concentrations at 6 months [Six Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Lhasa Prefecture and surrounding villages	Lhasa	Tibet	China	850000

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