Study of a Natural Chelator’s Effect on Autism Expanded and Renewed
As the first ever clinical study examining a natural chelator’s effect on autism disorders moves into it’s second year, it’s expanded protocol was approved by its FDA approved Independent Review Board. To date, approximately sixty children have been identified or accepted into the study. Recruiting will continue until the needed eighty children have been accepted and an additional twelve alternatives have been identified.
West Linn, OR, June 28, 2007 --(PR.com)-- Introduced in August 2005, the patented liquid zeolite product named NCD zeolite™, has generated a substantial number of anecdotal reports from the USA, Canada, England, Australia, New Zealand, the Philippines and Japan. The reports stimulated the Health and Wellness Research Institute, Portland, Oregon, to independently sponsor a randomized, double-blind, placebo-controlled clinical study evaluating the effects of including daily drops of the dietary supplement, NCD zeolite™ to the diets of children, ages three to eleven, with an autism disorder.
About one child in 150 develops autism or a related disorder by the age of 8, according to a study released in February by the Centers for Disease Control and Prevention. Children with classic autism have disabling difficulties in communicating, forming relationships and adjusting to change; those with other disorders on the spectrum have social difficulties generally less severe, and in some cases mild. Extrapolating from the number of cases it found, the study suggested that some 560,000 Americans age 21 or under struggled with such disorders.
The natural supplement, trade named, Natural Cellular Defense is purified clinoptilolite, a type of zeolite, suspended in solution. The zeolite is purified using a patented process and named NCD Zeolite™.
This form of zeolite is one of the few negatively charged minerals in nature, and it has a microscopic honeycomb-like crystalline structure of cavities and cages. Waste water studies show that this structure has the ability to attract, trap, bind and remove various heavy metals and toxins such as mercury, lead and arsenic.
The study uses a variety of established clinical instruments for autism treatment evaluation including the Pervasive Developmental Disorder Behavioral Inventory (PDDBI), the Autism Treatment Evaluation Checklist (ATEC) and the Autism Severity Scale.
Further, while other published and submitted studies with zeolite have demonstrated the ability for zeolite to remove heavy metals, this is the first study to test zeolite's ability to remove mercury, lead and other heavy metals from children with ASD. Nine Urinary Toxic Metal tests will be performed by Doctor's Data, Inc. for each child in the UTM test group. Laboratoire Philippe Auguste, Paris France, will provide both baseline and completion Urinary Porphyrin Profiles.
Initially, at the end of the 90-day study period, those receiving the placebo will then begin taking the liquid zeolite and be tracked for 90 more days. With the approved study expansion, all participants will receive the liquid zeolite. This expansion will allow the investigators to explore a number of additional questions.
Two sites have been approved. In Plano, Texas, Dr. Seshagiri Rao, a Board Certified Pediatrician is the lead investigator manages the participants from his practice and throughout the USA. The second site, in Baton Rouge, Louisiana is lead by Dr. Stephanie Cave who will manage participants drawn from her practice.
Professor James Adams, PhD will conduct the study data analysis. In addition, previously published studies on the high level of mercury toxicity common in many autistic children, Dr. Adams recently completed the clinical portion of the first ever double-blind clinical trial on a chelator and its effect of children with autism.
Mr. Forrist Lytehaause, Research Director of HWRI, said, “We are pleased with our steady recruitment progress. Word of mouth has continued to draw interest and requests for study applications.”
He does acknowledge, “With the ready availability of NCD zeolite™ without prescription, many parents, working with Defeat Autism Now (DAN) doctors and others, have chosen to incorporate liquid zeolite into their developmentally delayed child's biomedical protocol.”
“We are grateful for the help we've received from many parents in reaching out to local autism support groups and yahoo discussion groups.” reported Lytehaause.
Contact:
Forrist Tanner Lytehaause
(503) 699-4925
http://www.ZeoliteAutismStudy.com
About Health and Wellness Research Institute
Operating as a 501(c)(3) non-profit organization* whose mission is to provide sponsor research on potential solutions to the health problems related to environmental toxins. *Fiscal sponsor - Biomedical Research Institute of America, Inc.
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About one child in 150 develops autism or a related disorder by the age of 8, according to a study released in February by the Centers for Disease Control and Prevention. Children with classic autism have disabling difficulties in communicating, forming relationships and adjusting to change; those with other disorders on the spectrum have social difficulties generally less severe, and in some cases mild. Extrapolating from the number of cases it found, the study suggested that some 560,000 Americans age 21 or under struggled with such disorders.
The natural supplement, trade named, Natural Cellular Defense is purified clinoptilolite, a type of zeolite, suspended in solution. The zeolite is purified using a patented process and named NCD Zeolite™.
This form of zeolite is one of the few negatively charged minerals in nature, and it has a microscopic honeycomb-like crystalline structure of cavities and cages. Waste water studies show that this structure has the ability to attract, trap, bind and remove various heavy metals and toxins such as mercury, lead and arsenic.
The study uses a variety of established clinical instruments for autism treatment evaluation including the Pervasive Developmental Disorder Behavioral Inventory (PDDBI), the Autism Treatment Evaluation Checklist (ATEC) and the Autism Severity Scale.
Further, while other published and submitted studies with zeolite have demonstrated the ability for zeolite to remove heavy metals, this is the first study to test zeolite's ability to remove mercury, lead and other heavy metals from children with ASD. Nine Urinary Toxic Metal tests will be performed by Doctor's Data, Inc. for each child in the UTM test group. Laboratoire Philippe Auguste, Paris France, will provide both baseline and completion Urinary Porphyrin Profiles.
Initially, at the end of the 90-day study period, those receiving the placebo will then begin taking the liquid zeolite and be tracked for 90 more days. With the approved study expansion, all participants will receive the liquid zeolite. This expansion will allow the investigators to explore a number of additional questions.
Two sites have been approved. In Plano, Texas, Dr. Seshagiri Rao, a Board Certified Pediatrician is the lead investigator manages the participants from his practice and throughout the USA. The second site, in Baton Rouge, Louisiana is lead by Dr. Stephanie Cave who will manage participants drawn from her practice.
Professor James Adams, PhD will conduct the study data analysis. In addition, previously published studies on the high level of mercury toxicity common in many autistic children, Dr. Adams recently completed the clinical portion of the first ever double-blind clinical trial on a chelator and its effect of children with autism.
Mr. Forrist Lytehaause, Research Director of HWRI, said, “We are pleased with our steady recruitment progress. Word of mouth has continued to draw interest and requests for study applications.”
He does acknowledge, “With the ready availability of NCD zeolite™ without prescription, many parents, working with Defeat Autism Now (DAN) doctors and others, have chosen to incorporate liquid zeolite into their developmentally delayed child's biomedical protocol.”
“We are grateful for the help we've received from many parents in reaching out to local autism support groups and yahoo discussion groups.” reported Lytehaause.
Contact:
Forrist Tanner Lytehaause
(503) 699-4925
http://www.ZeoliteAutismStudy.com
About Health and Wellness Research Institute
Operating as a 501(c)(3) non-profit organization* whose mission is to provide sponsor research on potential solutions to the health problems related to environmental toxins. *Fiscal sponsor - Biomedical Research Institute of America, Inc.
###
Contact
Health and Wellness Research Institute
Forrist Lytehaause
503-699-4925
http://www.ZeoliteAutismStudy.com
Forrist Lytehaause
503-699-4925
http://www.ZeoliteAutismStudy.com
Contact
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