5024-0 webber naturals 6-25273-05024-0 NPN: 2241460 Class: Nutrient Calcium Magnesium 2:1 with Vitamin D Ingredients (alphabetical) Medicinal: Calcium (HVP chelate), magnesium (HVP chelate), vitamin D3. Non-medicinal: Cellulose, coating, croscarmellose sodium, magnesium stearate vegetable grade (lubricant). Allergens Corn, rice, soy, starch Source Refined mineral ores Uses Calcium is traditionally used for preventing or treating osteoporosis and prenatal nutrition during pregnancy, as well as high blood pressure in salt-sensitive cases and pregnancy induced high blood pressure [Murray, Michael T., 1996]. Vitamin D3 is used to facilitate absorption of the calcium in the gut, for the active resorption of calcium from the renal filtrate, and to facilitate calcium incorporation in the bones. Magnesium is used because long-term supplementation of calcium without magnesium is a risk factor for developing magnesium depletions. The 2:1 ratio recognizes a growing awareness that magnesium is an important bone nutrient. Magnesium is involved in a number of metabolic steps, including ATP production. Its depletion is a risk factor for heart attack and arrhythmias [Murray, Michael T., 1996] [Teo, K.K., et al, 1993] [Turlapaty, P., et al, 1980]. Magnesium plays a central role in forming and maintaining bone density and should be a part of any osteoporosis treatment program [Gaby, Alan R., 1994]. Recommended Amount The National Institutes of Health (NID) in the USA has updated the usual Recommended Daily Allowance (RDA) values, recommending the amounts listed below [Optimal Calcium Intake, 1994]. No formal recommendations for magnesium with calcium have been given, but in this product magnesium is 50% of the calcium content. The NIH Recommended Daily Elemental Calcium Intake: 1. Infants up to 6 months 400 mg 2. Infants 6 to 12 months 600 mg 3. Children 1 to 5 800 mg 4. Children 6 to 1 800 1200 mg 5. Teenagers & Young adults (11 24) 1200 1500 mg 6. Pregnant & Nursing women 1200 1500 mg 7. Women 25+, not menopausal 1000 mg 8. Women postmenopausal on estrogen 1000 mg 9. Women postmenopausal not on estrogen 1500 mg 10. Men 25 to 65 1000 mg 11. Men over 65 1500 mg UPDATED 3/23/2006 Calcium Magnesium 2:1 with Vitamin D, 350/175 mg/100 IU WN5024T PAGE 1 OF 5
Adverse Side Effects product monograph Calcium supplements are usually well tolerated in daily dosages up to 2000 mg. Higher amounts may contribute to kidney stone formation and soft-tissue calcium deposits [Murray, Michael T., 1996] [Whitaker, Julian, 1995]. Magnesium has been used up to 12 mg per kilogram of body weight without apparent adverse effect [Murray, Michael T., 1996]. Magnesium reduces the risk for kidney stone formation, increasing the solubility of calcium in urine formation [Gaby, Alan R., 1994]. Interactions A multi-mineral supplement in addition to calcium and magnesium supplementation will provide other important minerals thought to be a part of normal bone metabolism. These including manganese, copper, strontium, and silicon. Boron and vitamin K cannot be supplemented in Canada, but they are also crucial to bone density renewal. Both of these nutrients can be supplied in a diet that emphasizes fruits and vegetables. The following bullet points highlight known interactions. Calcium absorption is dependent on the presence of adequate vitamin D. The recommended daily intake is 400 IU for ordinary needs. Those who are seeking to arrest/reverse osteoporosis should consider 800 to 1000 IU per day unless contraindications exist. SEE PHARMACEUTICAL COMMENTARY Quinolones and tetracyclines combine with calcium, magnesium or other minerals. Concurrent use will render the antibiotics less effective. Minerals should be taken at least two hours apart from these antibiotics. Used long term, these antibiotics may produce mineral deficiencies [Graedon, Joe, Graedon, Teresa, 1995]. Penicillamine absorption is impaired by magnesium and many of the minerals in a multi-mineral supplement. Such supplements should be taken at least two hours apart from the antibiotic. Long-term use of Penicillamine can deplete the body of zinc and copper [Graedon, Joe, Graedon, Teresa, 1995]. Loop diuretics may cause the loss of calcium and magnesium from the body, frustrating efforts to address osteoporosis [Graedon, Joe, Graedon, Teresa, 1995]. Thiazide diuretics cause mineral losses, including calcium and magnesium. Long-term use could deplete the body of these and other minerals. Since many of those using thiazides could also be osteoporotic, supplementation of minerals may be necessary [Graedon, Joe, Graedon, Teresa, 1995]. Colchicine may impair magnesium absorption [Graedon, Joe, Graedon, Teresa, 1995]. Corticosteroids interfere with calcium absorption and metabolism. Long term use may contribute to or exacerbate osteoporosis [Graedon, Joe, Graedon, Teresa, 1995]. Barbiturates, phenobarbital, and dilantin interfere with the metabolism of vitamin D. Long term use may contribute to or exacerbate osteoporosis, or lead to osteomalacia. Vitamin D supplementation should be advised in proportion to needs [Graedon, Joe, Graedon, Teresa, 1995]. In older people where fat absorption is compromised, 800 IU may be appropriate. Etidronate (Didronel) reacts with calcium and magnesium interfering with its absorption, if the respective dosing are not separated by at least two hours. However, this drug also alters vitamin D metabolism so that calcium deficiencies may result [Graedon, Joe, Graedon, Teresa, 1995]. Calcium interferes with iron absorption [Graedon, Joe, Graedon, Teresa, 1995]. Isoniazid alters vitamin D metabolism with possible reduction in calcium absorption. Supplementation with vitamin D at the optimal dose for individual needs should be advised [Graedon, Joe, Graedon, Teresa, 1995]. High doses of magnesium, zinc, fiber, and oxalates interfere with calcium absorption [Murray, Michael T., 1996]. Caffeine, alcohol, phosphates (from soft drinks, meat, and many can goods), protein (amino acids), sodium, and sugar increase calcium excretion [Murray, Michael T., 1996]. Digitalis may adversely affect magnesium status. Magnesium depletion is associated with an adverse heart impact, including arrhythmia and coronary spasms [Teo, K.K., et al, 1993] [Turlapaty, P., et al, 1980]. High intake of calcium and vitamin D fortified dairy foods decrease magnesium absorption [Murray, Michael T., 1996]. UPDATED 3/23/2006 Calcium Magnesium 2:1 with Vitamin D, 350/175 mg/100 IU WN5024T PAGE 2 OF 5
Precautions / Cautions product monograph This product may not supply the optimal supplemental amount of vitamin D3 required by the user. In older osteoporotic patients with compromised fat absorption, the optimal daily intake of fat soluble vitamin D should be clinically determined to insure that disease modifying absorption of dietary calcium, renal re-absorption of calcium, and vitamin D-dependent bone incorporation of calcium is occurring. Contraindications Patients with hyperparathyroidism or cancer should not supplement with calcium unless directed by a physician. Pharmaceutical Commentary Calcium supplementation addresses osteoporosis prevention and treatment. However, this disorder is not principally due to a lack of calcium, but to an imbalance in the bone remodeling action of the osteoclast cells that break down bone, and the osteoblast cells that build up new bone. Remodeling imbalance presents a wider therapeutic issue, which mineral supplementation cannot in itself address. However, achieving optimal mineral conditions is a critical step. Other factors like lifestyle or hormonal therapy will address remodeling imbalance. All calcium deficiencies if uncorrected will lead to bone disorders, especially in growing children, but not all cases of osteoporosis are the direct result of dietary calcium deficiency. Other considerations are important beyond calcium, and life style is central. The typical North American diet has the potential for causing excessive bone calcium mobilization that can lead to calcium wastage via urine excretion. High phosphate intake via meats and soft drinks, high sugar intake, and excessive plasma amino acid concentrations from excessive protein intake require calcium buffering, representing chronic drains on calcium bone density. Important lifestyle factors that influence the mineral density of bones are exercise and smoking. Many adults who work in sedentary jobs stop exercising in meaningful ways early in life. Yet, daily minimal weight-bearing exercise is able to drive bone formation, assuming dietary needs are met. Smoking is thought to ultimately lead to the potential for lower blood ph due to compromised CO2 venting in the lungs, thus allowing higher levels of carbonic acid to accumulate in the blood. Accordingly, more bone minerals will be mobilized to buffer the blood. Perhaps no mineral has gained greater recognition and acceptance than that of calcium. We are constantly admonished to, take calcium, in order to have strong bones now, and the acquired bone density needed for our latter years to avoid bone fractures due to osteoporosis. Osteoporosis concerns are well founded in North America, where approximately 1.3 million women suffer fractures each year as a result of osteoporosis. And to add concern, the rate of osteoporosis fractures has been going up over the past three decades in a manner that cannot be fully explained simply by the increase in an aging population [Gaby, Alan R., 1994]. Part of the problem in curbing the incidence of osteoporosis is a wide spread singular focus on calcium, with little or no emphasis on magnesium and vitamin D, and often only lip service to other critical mineral factors and meaningful exercise. Avoiding osteoporosis is much more complex than simply increasing calcium intake, or even relying on appropriate supplementation alone. It is important to realize that osteoporosis is an infrequent disease in the so called third world, where calcium supplementation, and milk consumption for that matter, is virtually non-existent and daily dietary calcium intake is typically below the average intake of North Americans [Gaby, Alan R., 1994]. However, the level of weight-bearing exercise is consistently higher. As much as 50% of the body s magnesium is found in the bones, pointing to the importance of magnesium to bone health. While calcium is the central mineral in bone mineralization or calcification, the quality of the calcium crystals formed is profoundly dependent on magnesium. When too little magnesium is available, the calcium crystals are weaker permitting fractures to occur, even when consistent efforts have been made to consume the recommended daily calcium supplements [Cohen, L., Kitzes, R., 1981]. Magnesium also provides a general alkalizing effect on the body s ph thus helping to avoid the need to sacrifice bone calcium as a buffer. Vitamin D performs three indispensable functions in developing and maintaining bone mineral density: (1) it facilitates dietary or supplemental calcium absorption from the intestines, (2) it decreases urinary calcium losses due to normal kidney filtration by facilitating resorption of calcium from the filtrate, and (3) it facilitates the incorporation of calcium into the bones [Murray, Michael T., 1996] [Gaby, Alan R., 1994]. Even a subtle protracted deficiency of vitamin D leads to increased risk of bone loss over time and osteoporosis fractures [Compston, J.E., 1998]. Numerous studies document that up to 80% of all hip fracture patients may exhibit vitamin D deficiency [Brown, Susan E., 1996 ]. There is a growing clinical recognition of vitamin D deficiency in the general population, leading to the conclusion that current levels of so-called adequate intake are too low [Compston, J.E., 1998] [Thomas, Melissa K., 1998] [Utiger, Robert D., 1998]. Separate clinical investigations using 700 and 800 UPDATED 3/23/2006 Calcium Magnesium 2:1 with Vitamin D, 350/175 mg/100 IU WN5024T PAGE 3 OF 5
IUs instead of the usual 400 IUs have demonstrated lower hip fracture rates compared to placebo [Utiger, Robert D., 1998]. The omission of supplemented vitamin D by those with already thinned bones or full-blown osteoporosis is certainly a strategic error in judgment. The margin of safety is substantial for vitamin D, with toxicity being associated with a daily amount greater than 2400 IUs, allowing an easy comfort level with 800 to 1000 IUs per day for adult bodies [Utiger, Robert D., 1998]. Other nutritional factors are known to participate in bone formation and renewal, such as Vitamin K, Manganese, Folic Acid, Boron, Vitamin B-6, Zinc, Strontium, Copper, Silicon, and Vitamin C. These can be obtained in a diet of fruit and vegetables and whole grains, as well as supplementing. Calcium supplementation has also been helpful in cases of salt-sensitive high blood pressure, as well as in pregnancy induced high blood pressure [Murray, Michael T., 1996] [Belizan, J.M., et al, 1991] [Knight, K. B., et al, 1992]. UPDATED 3/23/2006 Calcium Magnesium 2:1 with Vitamin D, 350/175 mg/100 IU WN5024T PAGE 4 OF 5
5024-0 References Belizan, J.M., et al, Calcium supplementation to prevent hypertensive disorder of pregnancy, New England Journal of Medicine, 325: 1399-1405,1991 Brown, Susan E., Better Bones, Better Body, Keats Publishing, New Canaan, CT, 1996 Cohen, L., Kitzes, R., Infrared spectroscopy and magnesium content of bone mineral in osteoporotic women, Israel Journal of Medical Science, 17: 1123-1125, 1981 Compston, J.E., Vitamin D Deficiency: time for action, editorial, British Medical Journal, 317: (Nov 28), 1466-1467, 1998 Dawson-Hughes, B., et al, Rates of bone loss in postmenopausal women randomly assigned to one of two dosages of vitamin D, American Journal of Clinical Nutrition, 61: 1140-1145, 1995 Editorial, Citrate for calcium nephrolithiasis, Lancet, I: 955, 1986 Gaby, Alan R., Preventing and Reversing Osteoporosis, Prima Publishing, Rocklin, CA, 1994 Germano, Carl, The Osteoporosis Solution, Kensington Books, New York, 1999 Graedon, Joe, Graedon, Teresa, Deadly Drug Interactions, St Martin s Griffin, New York, 1995 Knight, K.B., et al, Calcium supplementation on normotensive and hypertensive pregnant women, American Journal of Clinical Nutrition, 55: 891-895, 1992 Murray, Michael T., Encyclopedia of Nutritional Supplementation, Prima Publishing, Rocklin, CA, 1996 Optimal Calcium Intake, NIH Consens Statement Online, 1994, June 6-8; 12(4):1-31 Teo, K.K., et al, Role of magnesium in reducing mortality in acute myocardial infarction: A review of the evidence, Drugs, 46: 347-359, 1993 Thomas, Melissa K., Hypovitaminosis D In Medical Inpatients, New England Journal Of Medicine, 338:12, 777-783,1998 Turlapaty, P., et al, Magnesium deficiency produces spasms of coronary arteries: Relationship to etiology of sudden ischemic heart disease, Science, 208: 199-200,1980 Utiger, Robert D., editorial, The Need For More Vitamin D, New England Journal Of Medicine, 338:12, 828-829, 1998 Whitaker, Julian, Dr Whitaker s Guide to Natural Healing. Prima Publishing, Rocklin, CA, 1995 CONCERNS? COMMENTS? CALL 1.800.430.7898 For more monographs go to: www.webbernaturals.com/downloads.html UPDATED 3/23/2006 Calcium Magnesium 2:1 with Vitamin D, 350/175 mg/100 IU WN5024T PAGE 5 OF 5