Zetpil™ Calcium and Magnesium Suppository

A Trio of Essential Nutrients

1. Calcium

Most people only see calcium as essential to strong bones and teeth, and while 99% of the body’s calcium is found at these two sites, calcium has multiple functions in our bodies.   Calcium is essential for the regulation of blood clotting, sending and receiving nerve signals, contracting and relaxing muscles, releasing hormones and other chemicals, and keeping a normal heartbeat.  Although osteoporosis and osteopenia are the primary diagnoses of calcium deficiency, other serious health issues can occur with calcium deficiency.  These include, but are not limited to:

• arthritis and joint pain,
• muscle cramps, spasms, and twitches,
• nervousness,
• neuromuscular excitability,
• eczema,
• high blood pressure,
• back pains (sciatica, disc problems),
• panic attacks and depression,
• insomnia, and
• periodontal disease.

2. Magnesium

“Magnesium has been recognized as a cofactor for >300 metabolic reactions in the body, (and therefore) plays a major role in disease prevention and overall health. There is no major food that provides an extremely high amount of magnesium” and therefore supplementation is crucial to maintaining healthy, normal magnesium levels. ^{http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3650510/} Due to its multitude of actions within the body, magnesium deficiency is often an overlooked clinical diagnosis which is troublesome because correcting this deficiency is relatively easy with broad positive effects.

Low levels of magnesium have been associated with a number of chronic diseases including, but not limited to:

• migraine headaches,
• Alzheimer’s disease,
• cerebrovascular accident (stroke),
• type 2 diabetes mellitus,
• hypertension and cardiovascular disease. ^{http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3592895/}

“Loop and thiazide diuretics (often prescribed for hypertension and/or congestive heart failure), can further exacerbate magnesium loss, typically through the urine.”  ^{http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3650510/}

3. Vitamin D

There is now overwhelming scientific research that low Vitamin D3 levels and the associated calcium deficiency are linked with some cancers (e.g. renal, prostate, endometrial, ovarian, esophageal, gastric, pancreatic, bladder),  Hodgkin’s and non-Hodgkin’s lymphoma as well as cardiovascular disease, neuromuscular dysfunctions, Diabetes mellitus Type I, gingivitis, tooth decay and tuberculosis.  Recent research suggests that current FDA recommendations are grossly inadequate to maintain healthy, disease-preventing levels of vitamin D.

Previously, the recommended level of vitamin D was between 40 to 60 ng/ml, but more recently the optimal vitamin D level has been raised to 50-70 ng/ml, and when treating cancer or heart disease, as high as 70-100 ng/ml.  Therefore, the current guidelines recommending 600-800ius/day of vitamin D supplementation without appropriate serum testing to maintain adequate levels is a horrible disservice.

Individuals MUST obtain their vitamin D serum levels from blood testing, supplement accordingly, and then re-test to ensure proper absorption and level increases.  There are no arbitrary dosages and this process is the only one that will ensure appropriate vitamin D levels.

Calcium, Magnesium and Vitamin D deficiency lead to Osteoporosis

Clinical trials have demonstrated that calcium and vitamin D deficits are major risk factors for osteoporosis. Currently, osteoporosis and low bone mass are estimated to be a major health threat for almost 44 million U.S. men and women aged 50 and older, representing 55% of the population. While osteoporosis can be described as a childhood deficiency disease that expresses itself in old age, it should not be considered part of the normal aging process. Osteoporosis is a metabolic bone disease that is characterized by low bone mass and deterioration of bone tissue leading to bone fragility and increased risk of fracture. Simply put, thinning bones lead to fractures.

Therefore, if you have already been diagnosed with osteopenia or osteoporosis, you may have been deficient for a long time and are risk for many of the conditions mentioned above. Many people have been told they are getting adequate Calcium and Vitamin D from their diet or by taking over the counter oral supplements or prescription medications. However, is this really true or merely hype?

Why what you have been told may not be scientifically valid…..

First, to repeat from the information above, the most important piece of information is to understand how much elemental calcium is absorbed from supplements.  Calcium citrate products, most often recommended by medical practitioners, will not afford you the levels of elemental calcium necessary to maintain optimal levels and prevent calcium deficiency-related health issues.

Second, there are a number of food combinations and other dietary factors that block calcium absorption from the intestines, including, but not limited to:

• High intake of oxalates and phytates (found in foods such as spinach and whole grains)
• Consumption of alcohol, coffee, caffeinated beverages, energy drinks, and sugar
• Medications:
  • Anti-seizure medications,
  • Benzodiazepines (e.g. Xanax, Valium, Ativan),
  • Thyroid medications,
  • Diuretics, and
  • Aluminum-containing antacids (e.g. Tums).

Third, low estrogen levels in women and low testosterone levels in men will also further reduce elemental calcium absorption to levels as low as 8-10%.

Fourth, inadequate levels of Vitamin D3 (below 40ng/mL) will also negatively affect adequate calcium absorption.

Finally, this product is especially important for patients who suffer from subclinical nutrient malabsorption, conditions in which nutrient malabsorption is a fundamental part of the disease (i.e. celiac disease, Crohn’s Disease, Cystic Fibrosis) or have undergone surgical malabsorption procedures including but not limited to Roux en Y Gastric Bypass Surgery, Biliopancreatic Diversion, Duodenal Switch, Gastric Sleeve (VSG), Vertical Banded Gastroplasty (VBG) WLS-Bypass and Gastric Band and Mini Gastric Bypass Surgery.

Oral calcium forms (even the better forms such as calcium citrate) will not meet the needs of most patients and certainly not meet of the needs of the patients with obvious deficiencies.

The Zetpil™ Calcium and Magnesium Suppository is a SAFE ALTERNATIVE to Bisphosphonates (Fosamax, Actonel, Zometa and Boniva)

As described above, many healthcare professionals believe that the best way to treat and/or prevent osteoporosis or osteopenia is by the dietary intake of foods containing calcium and/or the use of oral calcium supplements.  However, the inability of many individuals to ingest and absorb adequate calcium levels prompted the pharmaceutical industry to develop a new class of medications called bisphosphonates (http://en.wikipedia.org/wiki/Bisphosphonate).  Aggressive marketing has influenced many in the medical community to tout these pharmaceutical drugs (Fosamax, Actonel, Zometa and Boniva) as the best preventative approach or even the best treatment approach for osteoporosis and/or osteopenia.

However, there are many medical professionals who are warning that the side effects and risks of these medications do not outweigh their purported benefits.

• First, bisphosphonates work by inhibiting bone resorption. Unfortunately that’s not as good as it may sound.  Bone formation requires a certain amount of bone resorption.  Therefore, if resorption (e.g. bone loss) is delayed, then so is new bone formation.  In fact, the development of osteonecrosis (bone decay) with the use of Fosamax may be based on this effect.

• Second, these medications still require adequate intake of calcium and vitamin D.

“Ensuring adequate calcium and vitamin D intake both before and after initiation of bisphosphonate therapy is an extremely important but frequently overlooked aspect of providing optimal care of skeletal health. Vitamin D insufficiency is widely acknowledged to be prevalent in nearly all patient populations prescribed bisphosphonate therapy, particularly in the elderly.” ^{http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2704135/}

• Third, it is well known in the medical community that medications have side effects. While some side effects of bisphosphonates are minor/common such as bone, muscle and joint pain, constipation, or flu-like symptoms, others can be severe such as rash, difficulty breathing, chest pain, severe heartburn, or swelling in the hands, legs, feet or jaw.   In fact, the use of Fosamax and Fosamax D have been linked to the painful and often disfiguring and irreversible condition osteonecrosis (bone decay) of the jaw (also referred to as ONJ, Dead Jaw of Bis-Phossy Jaw), hip, shoulder or knees.   Remarkably, Fosamax is still the most prescribed medication for osteoporosis/osteopenia.

Drs. Kurt Kennel and Matthew Drake out of the Mayo Clinic co-authored an excellent article (published in 2009 in the Mayo Clinic Proceedings) on the side effects of bisphosphonates and will serve as an indispensable reference for those looking to understand the risks of these medications.  Please visit this website for a full-text copy of this article. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2704135/

Supplement Facts

Recommended use:  2-3 Calcium/Magnesium per day or as directed by your health care professional.

Note: Two (2) packages (60 suppositories) of the Zetpil™ Calcium and Magnesium Suppository supplies a 30 day course of calcium replacement therapy and it has been observed that restoration of calcium levels in individuals experiencing intestinal malabsorption requires long-term supplementation.  However, serum calcium levels should be assessed every 6 months.

WARNINGS

• Although safe for children, this product should be kept out of the reach of children.
• Do not use if the suppositories are open or damaged.
• As with any nutrient if you are pregnant or breastfeeding, seek the advice of a health care provider before using this product.

This product is contraindicated in individuals with a known hypersensitivity to phospholipids, or any of the ingredients and should avoid taking this product.

Individuals that have chosen to take this product as part of a personal nutrient program have overwhelmingly chosen to utilize this product as a rectal suppository.  However, this product can also be taken safely by mouth. If one chooses to take this product orally, then this product may be considered a dietary supplement in accordance with current FDA guidelines.

If you choose to use this product as a rectal suppository, it is highly recommended you attempt to clear your bowels prior to inserting it to avoid premature evacuation.  To facilitate insertion it is recommended you moisten the product by passing it under a stream of cool water or use a personal lubricant. When used as a suppository, this product requires 15-20 minutes retention to ensure the complete absorption of the bioactive ingredients. This suppository can be inserted in any position. Although not required, if inserted while lying on one’s side, consider remaining in the supine position for 1-3 minutes following insertion. (Always insert flat end of suppository first).

Disclaimer: These statements have not been evaluated by the FDA. This product is a Federal Food, Drug, and Cosmetic Act compliant combination of naturally derived FDA GRAS (Generally regarded As Safe) herbal, nutraceutical, vitamins, minerals and amino acids products legally sold in the USA.  In accordance with FDA regulations, when taken orally, this product may be considered a dietary supplement as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).

Also, this product consists ONLY of a combination of naturally derived FDA GRAS (Generally regarded As Safe) herbal, nutraceutical, vitamins, minerals and amino acids products legally sold in the USA. Therefore, this product cannot be considered a drug as defined in section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). This product is not intended to affect the structure or function of the body and is not intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. Any nutritional suggestions and research regarding this product are provided for informational purposes only, and are not intended to diagnose, treat, cure or prevent disease nor should any information provided be used as a  substitute for sound medical advice.