Effects of CaNa2 EDTA (Detoxamin®) Suppositories on Heavy Metal Chelation; Excretion of Toxic Metals
- To assess the heavy metal chelation effect of Detoxamin on mobilization of Pb, Hg, Cd, As, Fe, and other metals in humans as determined by blood, urine, feces, and hair.
- To assess the safety of Detoxamin as measured by symptom inventory, serum chemistry, blood lipids, and selected inflammatory markers in humans.
- To determine whether Detoxamin heavy metal chelation is associated with alteration in markers of oxidative stress.
- To assess the variability in urinary excretion of selected metals from baseline to 90-day endpoint, following DMPS IV push, in non-treated human controls.
Heavy Metal Chelation Results Summary
A formidable amount of data exists that clearly indicate the insidious toxicity of non-physiological metals such as mercury, lead, nickel, cadmium, arsenic and aluminum where specific mechanisms for the neurotoxic, nephrotoxic and immune-dysregulatory effects of these metals are identified. A major portion of the population is at risk for chronic, low-level exposure to toxic heavy metals from environmental and occupational sources, as well as dental materials. This clinical interim clinical pilot trial has evaluated the safety and efficacy of a recently developed suppository formulation delivery of CaNa2 EDTA. Suppositories provide direct access to the systemic circulation, efficiently bypassing portal circulation and liver metabolism via the hemorrhoidal veins on the first pass. The study examined the ability of Detoxamin EDTA suppositories for heavy metal chelation to remove a variety of the most prevalent toxic heavy metals as determined by excretion in urine and feces. Twelve healthy adult subjects, ranging from 25 to 65 years of age, were administered Detoxamin EDTA suppositories suppositories over a course of 90 days. Excretory specimens were evaluated on 0 (pre-treatment), 3 and 90 days post-treatment. An initial provocation with DMSA was given orally several days before the Day 0 samples were taken and again on Day 90 post-treatment. Detoxamin EDTA suppositories for heavy metal chelation appear to be a safe and effective means to slowly and consistently remove a variety of toxic heavy metals as evidenced by urine and fecal analysis. There is increased need and demand for more consumer friendly, less invasive, less time-consuming broad specificity heavy metal chelation protocols consistent with the time constraints and health goals of many members of our society today.
A plethora of published biomedical studies clearly indicate the insidious toxicity of non-physiological metals such as mercury, lead, cadmium and aluminum, and the specific mechanisms for the neurotoxic, nephrotoxic and immune-dysregulary effects of the metals have been well elucidated. To date, DMPS (iv and po) DMSA (po) and slow-drip Na2-EDTA for heavy metal chelation have been appropriately evaluated for efficacy in both acute and chronic metal toxicity. The USEPA, FDA, CDC and State Health departments recognize the growing global problem of chronic low level exposure to toxic metals; however the prevailing criteria for initiation of heavy metal chelation treatment fall short of the more rigorous standards of those who practice preventative/comprehensive medicine versus crisis management. Na2-EDTA is FDA approved for lead chelation (also chelates other metals), but the most common method of heavy metal chelation administration (slow-drip intravenous method) is very expensive, invasive and far too time-consuming for most adults in our fast-paced society.
Adults are at risk for chronic, low-level exposure to toxic metals from environmental and occupational sources, as well as dental materials. Furthermore, aging is associated with increased risk for chronic, low-level re-exposure to lead because the vast majority of lead is sequestered in bone and dissolution of the bone matrix is a common problem with aging. Lead, released from the bone, where it is relatively inert, has a far greater adverse effects when it is subsequently taken up by extremely vulnerable cells in the central and peripheral nervous system, heart and kidneys. The bottom line: there is increased need and demand for more consumer friendly, less invasive, less time-consuming broad specificity heavy metal chelation protocols that are consistent with the time constraints and health goals of many members of our society today.
Detoxamin EDTA Suppositories provide a safe and effective alternative to the expensive and invasive traditional slow drip EDTA protocol for heavy metal chelation and detoxification. The fact that CaNa2-EDTA administered rectally might be an effective means for Hg detoxification is in sharp contrast to the relative inefficiency of traditional EDTA heavy metal chelation, which is based upon urinary excretion.
Within the era of cost-containment and the risk of AIDS and other communicable blood-borne diseases, time constraints and affordability issues, suppository drug delivery is becoming a more viable option for doctors and patients. Suppositories provide direct access to the systemic circulation, efficiently bypassing the portal circulation and the liver metabolism on the first pass. It is a little known fact that the lower and middle hemorrhoidal veins bypass the liver and do not undergo first-pass metabolism. Therefore, suppositories can deliver the drug rapidly to the lower and middle hemorrhoidal veins for absorption. The rectum is an interesting area for drug absorption because it is not buffered and has a neutral pH. It also has very little enzymatic activity, thus enzymatic degradation does not occur. The rectal mucosa is more capable than the gastric mucosa of tolerating various drug-related irritations. This is especially important in patients with gastric disease. The anorectal physiology provides a large surface area for drug absorption. Another factor that is important in drug delivery is drug solubility. The osmosis process allows the drug to transfer from the vehicle in the suppository, across the membrane of the rectum, and into the hemorrhoidal veins. As we become more aware of the potential complications of infection associated with the use of IVs, suppository administration provides a preferable alternative.
The body sequesters mercury, Hg, in the liver by binding it to cholesterol and converting it into bile that then flows into the intestines. As bile is used to breakdown dietary lipids, some of the Hg becomes unbound in the intestinal tract. Detoxamin CaNa2-EDTA Suppositories deliver the heavy metal chelation ability just where the maximum Hg mercury chelation and excretion is taking place.