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.
Portland, Oregon – June 22, 2007
Introduced in August 2005, the original liquid zeolite product, 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 evaluting the effects of including daily drops of the dietary supplement, this liquid 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.
A new study published May 15, 2007 in the Journal of Toxicology and Environmental Health by Geier and Geier clearly suggests there is a direct causal link between mercury exposure from Thimerosal-preserved vaccines and autism spectrum disorders (ASD). Thimerosal (49.55% mercury by weight) is a highly toxic mercury compound used as a preservative in some OTC and prescription drugs, including most flu shots given to pregnant women, infants, children, adults, and the elderly.
In the June 2007 issue of the same journal, a study by J. B. Adams, et al, titled “Mercury, Lead, and Zinc in Baby Teeth of Children with Autism Versus Controls” was published. According to the authors, “Children with autism have 3x as much mercury in their baby teeth.” Tthey continue with a recommendation: “Preventing mercury exposure could prevent many cases of autism. Removal of heavy metals may help reduce autistic symptoms, especially in young children.”
On April 19, 2007, Dr. Larry L. Needham, Chief, Organic Analytical Toxicology Branch, CDC, announced to the US National Academy of Sciences' Institute of Medicine that Thimerosal was among the "Chemicals Linked to ASD."
The natural supplement, liquid zeolite, is purified clinoptilolite, a type of zeolite, suspended in solution. The zeolite is purified using a special process.
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.
Dr. 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 Health and Wellness Research Institute, 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, “Even though all the expenses for the study participants are covered by the study sponsor, with the ready availability of this particular liquid 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.” reported Lytehaause.
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References:
1. www.cdc.gov/od/oc/media/pressrel/2007/r070208.htm
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=174545603.
3. zeoliteautismstudy.com/ppt/Needham-final-2004_19_07.pdf
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NOTE: Study participants will NOT have to pay for the liquid zeolite used during the study. Only people from the USA except Massachusetts, Florida and Hawaii, who have not used liquid zeolite in the past and other criteria may participate. Applying for the study does not insure acceptance. The study design is restricted to children from 3 to 11 due to the limitations of the available instruments used to measure changes in autism.
o At the request of the manufacturer, the actual product name is no longer on the site. If you have any questions about what the actual product is, call us at (503)699-4925.
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