Study in Natural Detoxification and Chelation.
A research study to determine the effect of a Detoxification Protocol on autistic children who have high levels of mercury. The purpose of our study is to quantify the effects of natural detoxification protocols, natural chelation agents and compare such protocols to the same used with synthetic chelators. We are seeking information that contrasts the function of different detoxification and chelation agents and to see how such agents are enhanced and reinforced through the application of naturopathic agents that include nutritional supplementation through natural means. Thus forty families on TD-DMPS reinforced with a natural protocol, forty on a new natural chelator from Russian research with the same naturopathic protocol, forty more children on the naturopathic protocol only, and forty control subjects will be included in the study.
The specific information that our study will provide is how high the recovery rates of autistic children can be pushed when TD-DMPS is used with an ideal natural protocol and how these rates compare to a similar group who use HMD, a natural chelator instead of the synthetic DMPS. Separately we will be studying the power of the naturopathic protocol alone and see how effective that is without the specific use of a chelator of any kind.
We will not be experimenting with or trying to prove the efficacy of any single detoxification element except for making a comparison between the choice of a synthetic chelator like TD-DMPS, which has known side effects and a natural chelation product like HMD which is not know to have any side effects. We find it unethical to experiment with the lives of children so are including everything possible in our study to get these children well. Thus the study is really about the overall design of a well thought out and carefully designed detoxification program that follows basic naturopathic and medical principles.
The Detoxification Protocol will consist of:
- Pure Bentonite Calcium Clay approved by the FDA for internal consumption
- Spirulina with Selenium
- Magnesium Oil used in footbaths with magnesium ceramic balls to restructure the water.
- Activated Carbon
- HMD Heavy Metal Detox – A natural chelator made from chlorella and cilantro
- Tooth Paste without fluoride.
- Natural Clay Soap
- Non-toxic household cleaners
- Diatomaceous Earth (DE)
- MegaFood Vitamin C
- Zinc Supplementation
- Spring or Filtered Water (Ionized when possible)
The following is a summary of the testing protocol to which volunteers will sign an Informed Consent Form for:
Volunteer selection criteria: Volunteers selected will have mercury levels over the normal reference range on a Tissue Hair Mineral Analysis performed by IMC Research Laboratories, Cyprus using an Atomic Fluorescence Spectrometer with detection levels in parts per trillion.
Responsibilities of the Volunteer:
1) Provide a baseline hair sample (1 heaped tablespoon) from the nape of the neck initially to determine levels of mercury – those with high levels above the reference range will qualify for the research study. Those with levels within the normal range will not qualify to be included in this initial research study.
2) The children will begin taking the detoxification protocol as instructed in the detailed instructions provided (see DETOXIFICATION PROTOCOL DETAILS).
3) Post testing 60 days later to allow the baseline sample of hair to grow out. This will involve a further sample of hair from the nape of the neck to be sent for mercury testing. The baseline hair sample will be compared with the post-sample to determine differences.
4) 6 volunteers chosen at random from each group will also provide an initial urine sample as well as a post-urine sample two days later to determine the elimination of mercury in the urine. There will be no charge for this testing.
1) Provide hair sample as per Hair Collection Procedure. Send this to the address provided.
2) Fill out pre-study General Health Questionnaire.
3) Before, during and after the study participants will each week fill out the following:
|Eye contact||Very Poor||Poor||Some||Good||Excellent|
|Fine motor skills, (pressure in writing, creativity in drawing, length of time sitting to complete or create something)||Very poor||poor||average||good||Excellent|
|Regulation (impulse control, Hyper or calm and focus, or to calm and zoning out, jerky or fluid body movements)||Very Poor||Poor||Average||Good||Excellent|
|Social communication Self initiated||Poor||Some||average||Good||Excellent|
|Social communication Responses to others||Poor||Some||average||Good||Excellent|
During the 60 days period of study
1) Take DETOX PROTOCOL as instructed with all its components. Avoid having any dental work and vaccinations. Eat minimal levels of fresh fish.
After the 60 day period
1) Provide hair sample as per Hair Collection Procedures.
2) Complete follow-up health questionnaire.
Hair Samples: Hair samples were provided by each volunteer before the DETOX PROTOCOL was begun. Following completion of the 60-day period, a further hair sample will be taken.
Testing Laboratory Services Discussion
IMC Research Laboratories was selected as our preferred testing laboratory due to its reasonable pricing and established quality controls. Hair Elemental profiles are measured with ICP-OES Spectroscopy, and reported back with established comparative reference ranges along with actual results.
The IMC Research Laboratory also has extensive Quality Control processes that ensure precision and reliability which include calibration verification and monitoring standards; preparation blanks; laboratory controls and reference materials (low, medium, and high controls); spiked samples and duplicate analyses.
IMC Research Laboratories uses a modified version of the standardized sample preparation method published by the International Atomic Energy Agency (IAEA/RL/50, Vienna). This method consists of cutting the hair into .3cm pieces and mixing to obtain a representative sample, washing the hair three times with Acetone and Double Deionized Water (DDW) to remove external contamination. The sample is then weighed on a 4-decimal place weighing scale and then digested using trace metal free nitric acid concentrated with hydrogen peroxide and DDW and then analysed using ICP-OES spectrometer with an Atomic Fluorescence Mercury Analyser.