Antioxidant Supplementation in Patients With Kashin-Beck Disease

February 12, 2008 updated by: Innovative Humanitarian Solutions

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

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

Study Overview

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

September 12, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 14, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

February 1, 2008

More Information

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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