Vitamin D3


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Vitamin D3

  1. 1. Micellized Vitamin D3 A paradigm shift for all healthcare providers.
  2. 2. Diseases of Civilization <ul><ul><ul><li>Associated with vitamin D deficiency : Prostate cancer, colon cancer, breast cancer, 12 other cancers, heart disease, type-2 diabetes, metabolic syndrome, hypertension, stroke, osteoarthritis, rheumatoid arthritis, depression, dementia, multiple sclerosis, chronic pain, obesity, periodontal disease, Parkinson's disease, autoimmune disease, and, osteoporosis </li></ul></ul></ul>
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  4. 4. Vitamin D Deficiency <ul><li>Most whites are deficient </li></ul><ul><li>Virtually all African Americans are deficient </li></ul><ul><li>Most vitamin D comes from the sun </li></ul><ul><li>Vitamin D is a prehormone, not a vitamin </li></ul><ul><li>If you avoid the sun, and do not take adequate doses of cholecalciferol, you are deficient </li></ul>
  5. 5. Vitamin D Deficiency Dickey, who is immediate past president of the American Academy of Clinical Endocrinologists, also points out research is pointing to more and more cases of vitamin D deficiency in the U.S. and Northern Europe. &quot;We now have an epidemic of vitamin D deficiency in our elderly and possibly our younger people .&quot; Vitamin D deficiency in the young can also coincide with the peak time in bone formation as well.
  6. 6. <ul><li>Calcitriol is perhaps the most potent anti-cancer agent known to man </li></ul><ul><li>It promotes normal cell death (apoptosis), cell specialization (differentiation), prevents vascularization (neoangiogenesis), and inhibits metastasis </li></ul><ul><li>Vieth showed it lowers PSA in prostate cancer </li></ul>
  7. 7. The current adult recommendations for vitamin D, 200-600 IU/d, are very inadequate when one considers that a 10-15 min whole-body exposure to peak summer sun will generate and release up to 20,000 IU vitamin D-3 into the circulation.
  8. 8. A person standing in the summer sun for an hour at noontime in a Southern latitude (Arizona, Florida) in swim trunks would naturally produce about 10,000 IU (250 micrograms) of vitamin D through skin exposure. Sun poisoning from vitamin D overdose has never been reported. [Am J Clinical Nutrition 73 (2): 288-94, Feb 2001; Am J Clinical How much Vitamin D should you take?
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  11. 11.  Vitamin D Nutritional Status Primates Humans Americans 1000 IU 4000 IU in sun in winter supplement supplement 60 55 15 25 40 Old-World Primates Humans with UV Canadian Winter Canadian + 25 ug/d Canadian + 100 ug/ d 0 40 80 120 160 Serum 25(OH)D nmol/L
  12. 12. Vitamin D levels in serum “M. Holick” 25 (OH) D Level ng/ml nMol/L Deficient less than 8 less than 14 Insufficient 8-30 12.5-50 Optimal 30-90 (60) 50-150 High 90-150 150-250 Toxic greater than 150 greater than 250
  13. 13. The winter mean winter concentration was 24.9 +/- 8.7 ng/ml in men and 22.4 +/- 8.2 ng/ml in women and the summer the mean concentration was 31+/-11ng/ml in men and 25 +/- 9.4 ng/ml in women.
  14. 14. J Clin Endocrinol Metab . 2007;92:2130-2135. ide without sunscreen and 28.9 hours per week outside with and without sunscreen, the authors report. This translates to a mean of 11.1 hours per week of total body skin exposure with no sunscreen used, the results indicate. Despite this abundant sun exposure, 51% of the subjects had serum 25-hydroxyvitamin D concentrations below 30 ng/mL, defined as &quot;low vitamin D status,&quot; the researchers report. The highest observed level was 62 ng/mL . &quot; This implies that the common clinical recommendation to allow sun exposure to the hands and face for 15 minutes may not ensure vitamin D sufficiency,&quot; the investigators say. Overall, vitamin D level did not correlate with age, skin color, or sun exposure, the report indicates. However, participants in the lowest vitamin D quartile compared to the rest of the participants had higher parathyroid hormone levels and lower sun exposure scores. &quot; Clinicians should not assume that individuals with abundant sun exposure have adequate vitamin D status,&quot; the authors conclude. They recommend that in treating vitamin D deficiency with vitamin D supplementation , &quot;it seems prudent&quot; to aim for a serum 25-hydroxyvitamin D concentration no greater than the maximum produced by natural UV exposure; i.e., approximately 60 ng/mL. Reuters Health Information 2007. © 2007 Reuters Ltd. Inadequate sun exposure is blamed for the high prevalence of low vitamin D. (But is this true?) In Hawaii despite abundant sun exposure without sunscreen 51% had low Vit D status below 30ng/ml.
  15. 15. 1,25(OH)(2)D(3) functions as a potent negative endocrine regulator of renin gene expression provides some insights into The concept of vitamin D regulation of blood pressure through the Renin-angiotensin System Modulation of Blood pressure regulation with Vit D
  16. 16. * <ul><ul><ul><li>Cardiovascular disease is more common in the winter, more common at higher latitudes and more common at lower altitudes </li></ul></ul></ul><ul><ul><ul><li>People with 25(OH)D levels above 35 ng/ml were half as likely to have a heart attack than those whose level was less than 35 ng/ml </li></ul></ul></ul><ul><ul><ul><li>John Connell MD </li></ul></ul></ul>
  17. 17. The women, 1,179 healthy, postmenopausal women who were all 55 years or older and free of known cancers for at least 10 years prior to entering the study, were randomly assigned to take daily dosages of 1,400-1,500 mg supplemental calcium, 1,400-1,500 mg supplemental calcium plus 1,100 IU of vitamin D3, or placebos. Over the four-year trial, women in the calcium/vitamin D3 group experienced a 60 per cent decrease in their cancer risk compared to the group taking placebos.
  18. 18. * <ul><ul><ul><li>In an eight-year prospective study of 25,000 subjects, colon cancer was reduced by 80% in those with serum 25(OH)D levels above 33 ng/ml </li></ul></ul></ul><ul><ul><ul><li>A recent English study showed breast cancer was five times more common in those with the lowest 25(OH)D levels </li></ul></ul></ul>
  19. 19. Sato reported that two years of treatment with 1,000 IU of vitamin D per day significantly increased muscle strength , doubled the mean diameter, and tripled the percentage of fast-twitch muscle fibers, in the functional limbs of 48 severely vitamin D deficient elderly stroke patients. The placebo control group suffered declines in muscle strength, and in the size and percentage of fast-twitch muscle fibers. Sato Y, Iwamoto J, Kanoko T, Satoh K. Low-Dose Vitamin D Prevents Muscular Atrophy and Reduces Falls and Hip Fractures in Women after Stroke: A Randomized Controlled Trial. Cerebrovasc Dis. 2005 Jul 27;20(3):187-192 [ Epub ahead of print]
  20. 20. Immunity and Auto-Immunity <ul><li>Multiple Sclerosis </li></ul><ul><li>Inflammatory bowl disease </li></ul><ul><li>Diabetes Mellitus -type 1- auto-immunity and insulin production </li></ul><ul><li>Rheumatoid Arthritis </li></ul><ul><li>Psoriasis </li></ul><ul><li>Promotes wound healing and immune support </li></ul>
  21. 21. .   The association was strong   (P<.005) among their 120 women with polycystic ovarian disease.   However, like dozens of other studies, the authors also found a strong inverse correlation between obesity and vitamin D levels - the higher the vitamin D levels the thinner the patients - and this may explain the association with HDL cholesterol.   Unfortunately, the authors did not look further at their data to see if the association with HDL held after correction for body weight. Hahn S, et al. Low Serum 25-Hydroxyvitamin D Concentrations are Associated with Insulin Resistance and Obesity in Women with Polycystic Ovary Syndrome. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):577-83.
  22. 22. Vitamin D improves low back pain . Initial assessment involved 360 patients (90% women and 10%men) who had experience low back pain that had no obvious cause for more than 6 months. Finding 83% n=299 had an abnormally low level of vitamin D . After treatment with Vit. D clinical improvement in symptoms was seen in 95% of all the patients n=341 Spine 2003 Jan 15;(2);177-9
  23. 23. Osteoporosis and Arthritis
  24. 24. CONCLUSIONS: In ambulatory adults on antiepileptic drugs , high-dose vitamin D 4,000 IU/day therapy substantially increased bone mineral density at several skeletal sites.
  25. 25. <ul><li>Framingham data showed osteoarthritis of the knee progressed more rapidly in those with 25(OH)D levels lower than 36 ng/ml </li></ul><ul><li>Another study found that osteoarthritis of the hip progressed more rapidly in those with 25(OH)D levels lower than 30 ng/ml </li></ul>
  26. 26. Cold and Flu Season
  27. 27. Flu Shots? <ul><li>A recent study published in the October issue of the Archives of Pediatric & Adolescent Medicine found that vaccinating young children against the flu appeared to have no impact on flu-related hospitalizations or doctor visits during two recent flu seasons. </li></ul><ul><li>The researchers concluded that &quot; significant influenza vaccine effectiveness could not be demonstrated for any season, age, or setting &quot; examined. </li></ul><ul><li>Additionally, a Group Health study found that flu shots do not protect elderly people against developing pneumonia -- the primary cause of death resulting as a complication of the flu. </li></ul>
  28. 28. <ul><li>One credible hypothesis that explains the seasonal nature of flu is that influenza is a vitamin D deficiency disease. Vitamin D levels in your blood fall to their lowest point during flu seasons. Unable to be protected by the body’s own antibiotics (antimicrobial peptides) that are released by vitamin D, a person with a low vitamin D blood level is more vulnerable to contracting colds, influenza, and other respiratory infections </li></ul>
  29. 29. <ul><li>In 1981, a British general practitioner named R. Edgar Hope-Simpson published the first paper documenting a link between influenza epidemics in the northern hemisphere and the winter solstice. The solstice - which arrives on Dec. 21 this year - is commonly identified with the start of winter and is the shortest day of the year.  Hope-Simpson, who had no formal training in epidemiology, realized that influenza infections tended to jump just before and after the solstice. Solar radiation, he surmised, triggered some sort of &quot;seasonal stimulus&quot; that affected the flu virus, its human host or both. </li></ul>
  30. 30. Honk Kong Pandemic in Britain
  31. 31. 25(OH)D levels and flu season
  32. 32. <ul><li>In their forthcoming paper in Epidemiology and Infection, John Cannell PhD and colleagues from Harvard University, the National Institutes of Health and Boston University propose that Hope-Simpson's seasonal stimulus could be vitamin D. The tip-off, says Cannell, came in April 2005, when an outbreak of influenza swept through Atascadero, a maximum-security facility for the criminally insane 200 miles south of San Francisco. </li></ul><ul><li>&quot;The ward below me got it, then the ward to my right, to my left and the one across the hall,&quot; he recalls. Cannell's 32 patients, however, were spared. As far as he could tell, there was only one glaring difference between his patients and those who came down with flu: Cannell's patients were taking high daily doses of vitamin D. </li></ul>
  33. 33. Information Sources <ul><li>“ The UV Advantage” Michael Holick and Mark Jenkins </li></ul><ul><li> </li></ul><ul><li>www. </li></ul><ul><li> </li></ul>
  34. 34. D3 Absorption Issues
  35. 35.
  36. 37. <ul><li>At the junction of membrane surface and body fluid, there is a double layer formation. This double layer is aqueous in nature. For a drug to cross the membrane and arrive at its site of action, it must cross this double layer before getting into the membranes. Absorption, regardless of the site, is dependent upon drug solubility in the double layer. The higher the solubility, the higher the absorption, therefore the higher the bioavailability. </li></ul>
  37. 38. Unstirred water Layer
  38. 39. Unstirred water Layer
  39. 40. Unstirred water Layer
  40. 41. Unstirred water Layer
  41. 43. How Well Does It Work?
  42. 44. How Well Does It Work? Before After
  43. 45. VITAMIN E - FIVE TIMES GREATER ABSORPTION Platelets play an important role in thrombus formation in arterial vascular walls which may lead to vascular disease. It has been suggested in the scientific literature that vitamin E exhibits anti-platelet activity. 5 However, the plasma level of vitamin E in oil form is found to be very low. The absorption of Vitamin E in oil form is lower than 25% in normal humans. 6 Dosage of 500 IU of d-alpha-tocopheryl acetate were administered to the 12 subjects and the plasma levels were measured as an increase over baseline levels (19.8 micromoles/liter) at 4 and 24 hours. Figure 3 shows the results of the comparative absorption increases of vitamin E plasma levels of the oil, emulsified and EMUSOL® form at 4 and 24 hours.
  44. 46. <ul><li>VITAMIN A - FIVE TIMES GREATER ABSORPTION </li></ul><ul><li>Human subjects were given 50,000 IU vitamin A palmitate in either an oil, emulsified or EMUSOL® form. The blood plasma levels were measured as an increase over baseline levels (2.675 micromoles/ liter) at 4 and 8 hours. Figure 5 illustrates results while Table 3 provides a summary of the relative increases. </li></ul>
  45. 47. <ul><li>References: </li></ul><ul><li>Goodman and Gilman’s “The Pharmacological Basis of Therapeutics”, Eighth Edition, pp 1-83, McGraw-Hill, 1990 </li></ul><ul><li>Thomas M Devlin “Biochemistry with Clinical Correlations” Third Edition, pp 1059-1091, Wiley-Liss, 1993 </li></ul><ul><ul><li>Lewis JM, Bodansky O, Birmingham J, Cohan SQ. Comparative absorption, excretion and storage of oily and aqueous preparations of vitamin A. J Paediatr 31, 496-508 (1947); </li></ul></ul><ul><ul><li>Kelleher J, Davies T, Smith CL, et al. The absorption of alpha tocopherol in the rat: the effect of different carriers and different dose levels. Int J Vit Nutr Res 42, 394-411 (1972); </li></ul></ul><ul><ul><li>Gross S, Melhorn DK. Vitamin E dependent anaemia in the premature infant III. J Paediatr 85, 753-759 (1974); </li></ul></ul><ul><ul><li>Jansson L, Londrota M, Tyopponen J. Intestinal absorption of vitamin E in low birth weight infants. Acta Paediatr Scand 73, 329-332 (1984); </li></ul></ul><ul><ul><li>Bateman NE, Uccellini DA. Effect of formulation on the bio-availability of retinol, alpha-d-tocopherol and riboflavin. J Pharm Pharmacol 36, 461-464 (1984); </li></ul></ul><ul><ul><li>Hittner HM, Speer ME, Rudolph AJ, et al. Retrolental fibroplasia and vitamin E in the preterm infant - comparison of oral versus intramuscular administration. Paediatrics 73, 238-249 (1984); </li></ul></ul><ul><ul><li>Traber MF, Kayden HJ, et al. Absorption of water-miscible forms of vitamin E in a pationt with cholestasis and in thoracic duct-cannulated rats. Am J Clin Nutr 44, 914-23 (1986); </li></ul></ul><ul><ul><li>Sokol RJ, Heubi JE, Butler-Simon N, et al. Treatment of vitamin E deficiency during chronic childhood cholestasis with oral d-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS). Intestinal absorption, efficacy and safety. Gastroenterology 93, 975-985 (1987); </li></ul></ul><ul><ul><li>Traber MG, Thellman CA, Rindler MJ, Kayden HJ. Uptake of intact TPGS, a water-soluble form of vitamin E by human cells in vitro. Am J Clin Nutr 48, 605-611 (1988) </li></ul></ul><ul><li>Bhargava HN, Narurkar A, Lieb LM. Using microemusions for drug delivery. Pharm Tech 12(3), 46-54 (1987) </li></ul><ul><ul><li>Machlin LJ, Filipski R, Willis AL, et al. Influence of Vitamin E on platelet aggregation and thrombocythemia in the rat. ProcSocExp Biol Med 149, 275-277 (1975); </li></ul></ul><ul><ul><li>Steiner M, Anastasi J. Vitamin E: an inhibitor of the platelet release reaction. J Clin Invest 57, 732-737 (1976); </li></ul></ul><ul><ul><li>Cox AC, Rao GHR, Gerrard JM, White JG. The influence of vitamin E quinone on platelet structure, function and biochemistry. Blood 55, 07-912 (1980); </li></ul></ul><ul><ul><li>Tangey CC, Diskoll JA. Effects of vitamin E deficiency on the relative incorporation of 14 c-arachidonate into platelet lipids of rabbits. J Nutr III, 1839-1845 (1981); </li></ul></ul><ul><ul><li>Steiner M. Effects of alpha-tocopherol administration on platelet function in man. Thromb Haemotas 49(2), 3-77 (1983); </li></ul></ul><ul><ul><li>Kuo P, Wilson, Godstein R. Effect of long-term vitamin E and linoleate supplementation on platelet aggregation in man. J Am Col N 3, 244-249 (1984) </li></ul></ul><ul><li>Klaskin G, Molander DW. The chemical determination of tocopherols in faeces and faecal excretion of vitamin E in man. J Lab Clin Med 39, 802-807 (1952) </li></ul>