Kashin-Beck DiseasePhase 2NCT00376025
Antioxidant Supplementation in Patients With Kashin-Beck Disease
A Phase 2 study testing Biological Antioxidant Supplementation in people with Kashin-Beck Disease, run by Innovative Humanitarian Solutions at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Kashin-Beck Disease
- What is being tested?
- Biological Antioxidant Supplementation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinically diagnosed patients with Kashin-Beck disease
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Don Heath, B.S. contact
China1 site, 1 recruiting
- Recruiting
Lhasa Prefecture and surrounding villages
Lhasa, Tibet, 850000
Don Heath
About this study
Official title: 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.
Read the 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.
- Conditions
- Kashin-Beck Disease
- Being tested
- Biological Antioxidant Supplementation
- Keywords
- Kashin-Beck Disease, Kashin-Beck Osteoarthropathy
- Medical subject headings
- Kashin-Beck Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Antioxidant SupplementationDietary supplement
Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months
Measured: One Year
Secondary outcomes (1)
Increase in serum selenium concentrations at 6 months
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startJul 2007
- Primary completionJan 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Kashin-Beck DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Humanitarian Solutions
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston - Victoria
- Investigators
- Richard Gunasekera, Ph.D., Study chair, University of Houston - VictoriaJeff C Cokenour, B.S., Principal investigator, Innovative Humanitarian SolutionsMinh Han, M.D., Principal investigator, Innovative Humanitarian Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376025
- Sponsor's protocol ID
- KB001
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2006
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1093/jn/136.3.595.
PubMed 16484530Kohrle J, Jakob F, Contempre B, Dumont JE. Selenium, the thyroid, and the endocrine system. Endocr Rev. 2005 Dec;26(7):944-84. doi: 10.1210/er.2001-0034. Epub 2005 Sep 20.
PubMed 16174820Xia 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. doi: 10.1093/ajcn/81.4.829.
PubMed 15817859Esworthy 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. doi: 10.1093/jn/135.4.740.
PubMed 15795427Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. doi: 10.1677/joe.1.05971.
PubMed 15749805Moreno-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. doi: 10.1093/ajcn/78.1.137.
PubMed 12816783Stamler 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. doi: 10.1001/jama.282.21.2012.
PubMed 10591383Harris 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. doi: 10.1056/NEJM200102013440504.
PubMed 11172165Utiger RD. Kashin-Beck disease--expanding the spectrum of iodine-deficiency disorders. N Engl J Med. 1998 Oct 15;339(16):1156-8. doi: 10.1056/NEJM199810153391611. No abstract available.
PubMed 9770565Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. doi: 10.1002/biof.5520190306.
PubMed 14757964Molecular Biology of selenium with its implications for metabolism. Raymond F. Burke, Division of Gastroenterology, division of Medicine and center in molecular toxicology, Vanderbilt University school of medicine, Nashville, Tenn 37232, USA
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Antioxidant Supplementation in Patients Suffering From Kashin-Beck Disease
- ClinicalTrials.gov ID
- NCT00376025
- Acronym / sponsor ID
- KB001
- Conditions
- Kashin-Beck Disease
- Keywords
- Kashin-Beck Disease, Kashin-Beck Osteoarthropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Innovative Humanitarian SolutionsUniversity, hospital or other
- Collaborators
- University of Houston - Victoria
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 14 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinically diagnosed patients with Kashin-Beck disease
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Antioxidant SupplementationSupplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate. | Dietary supplement | – |
Primary outcome
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months
Time frame: One Year
1 secondary outcome
Increase in serum selenium concentrations at 6 months
Time frame: Six Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
- Background: PubMed 16484530Moreno-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. doi: 10.1093/jn/136.3.595.
- Background: PubMed 16174820Kohrle J, Jakob F, Contempre B, Dumont JE. Selenium, the thyroid, and the endocrine system. Endocr Rev. 2005 Dec;26(7):944-84. doi: 10.1210/er.2001-0034. Epub 2005 Sep 20.
- Background: PubMed 15817859Xia 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. doi: 10.1093/ajcn/81.4.829.
- Background: PubMed 15795427Esworthy 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. doi: 10.1093/jn/135.4.740.
- Background: PubMed 15749805Beckett GJ, Arthur JR. Selenium and endocrine systems. J Endocrinol. 2005 Mar;184(3):455-65. doi: 10.1677/joe.1.05971.
- Background: PubMed 12816783Moreno-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. doi: 10.1093/ajcn/78.1.137.
- Background: PubMed 10591383Stamler 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. doi: 10.1001/jama.282.21.2012.
- Background: PubMed 11172165Harris 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. doi: 10.1056/NEJM200102013440504.
- Background: PubMed 9770565Utiger RD. Kashin-Beck disease--expanding the spectrum of iodine-deficiency disorders. N Engl J Med. 1998 Oct 15;339(16):1156-8. doi: 10.1056/NEJM199810153391611. No abstract available.
- Background: PubMed 14757964Chanoine JP. Selenium and thyroid function in infants, children and adolescents. Biofactors. 2003;19(3-4):137-43. doi: 10.1002/biof.5520190306.
- BackgroundMolecular Biology of selenium with its implications for metabolism. Raymond F. Burke, Division of Gastroenterology, division of Medicine and center in molecular toxicology, Vanderbilt University school of medicine, Nashville, Tenn 37232, USA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Heath, B.S. contact
Richard Gunasekera, Ph.D. study chair
University of Houston - Victoria
Jeff C Cokenour, B.S. principal investigator
Innovative Humanitarian Solutions
Minh Han, M.D. principal investigator
Innovative Humanitarian Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological Antioxidant Supplementation in people with Kashin-Beck Disease, run by Innovative Humanitarian Solutions at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff C Cokenour, B.S. (832-863-5690, jeff.cokenour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on FLACC or Word Graphic pain rating scale at 3, 6, 9 months (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376025, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008.