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Antioxidant Supplementation in Patients With Kashin-Beck Disease

I

Innovative Humanitarian Solutions

Status and phase

Unknown
Phase 2

Conditions

Kashin-Beck Disease

Treatments

Dietary Supplement: Biological Antioxidant Supplementation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

9 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

Trial contacts and locations

1

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Central trial contact

Jeff C Cokenour, B.S.; Don Heath, B.S.

Data sourced from clinicaltrials.gov

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