Antioxidant Supplementation in Patients With Kashin-Beck Disease

Phase 2

• Conditions: Kashin-Beck Disease

• Registration Number: NCT00376025
• Lead Sponsor: Innovative Humanitarian Solutions

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.

Study Timeline

• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Study Start: 2007-07
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-12
• Last Update Posted: 2008-02-22
• Primary Completion: 2009-01
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months	One Year

Secondary Outcome Measures

Name	Time	Method
Increase in serum selenium concentrations at 6 months	Six Months

Trial Locations

Locations (1)

Lhasa Prefecture and surrounding villages; 🇨🇳 Lhasa, Tibet, China