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D Supreme™ Supports replenishment and restoration of levels and Calcium absorption

Vitamin D SupremeTM benefits: OVERVIEW • Helps maintain bone mineralisation, Vitamin D Supreme provides a clinically useful dose of vitamin D3, strength and integrity 1000 IU per veggie cap, and in both K1 and the MK-7 form • Contains both K1 and K2 which of K2, which is highly bioavailable. Both of these forms of vitamin K are important for blood clotting, are important to our health: vitamin K1 (the naturally occurring form bone health and heart health of vitamin K in vegetables) and as MK-7, which is a product of fermentation and has the special property of metabolising slowly throughout the day. Most holistically oriented healthcare practitioners are aiming for vitamin D blood levels of between 50 - 100 ng/mL as optimal. Many patients will require a higher dose of vitamin D as found in Vitamin D Supreme to achieve this. D and K are essential for optimal bone1,4,7 and arterial health and for maintaining the immune system in proper balance. We now know how important vitamin K is for directing the transport of calcium into bone and teeth for optimal strength.8 Increasing the amount of vitamin D, via supplementation, in the presence of inadequate levels of vitamin K, can increase the risk of calcium deposition in arteries5 and soft tissue and have a very negative effect on artery elasticity. This is due to their interaction in the use of MGP, Matrix Gla Protein, which is a strong inhibitor of arterial calcification. The expression of MGP is vitamin D dependent and the gamma-carboxylation step,11 making it active, is vitamin K dependent. Together, vitamins D and K make a great team.

KEY FEATURES: The Importance of Vitamin D Worldwide, an estimated 1 billion people have inadequate levels of vitamin D in their blood, and deficiencies can be found in all ethnicities and age groups. Even in industrialised countries, such as here in Australia, doctors are seeing the resurgence of rickets, the bone-weakening disease that had been largely eradicated through vitamin D fortification. Being deficient in vitamin D may increase the risk of a host of chronic diseases, such as osteoporosis,2 heart disease, some cancers, and multiple sclerosis, as well as infectious diseases, such as tuberculosis and even the seasonal flu. Vitamin D is both a nutrient we eat and a hormone our bodies make. Vitamin D helps ensure that the body absorbs and retains calcium and phosphorus, both critical for building bone.8 Laboratory studies show that vitamin D can reduce cancer cell growth and plays a critical role in controlling infections. Many of the body’s organs and tissues have receptors for vitamin D, and scientists are still teasing out its other possible functions. Recent studies are showing vitamin D may play a role in cardiovascular health, helping to control blood pressure and preventing arterial damage.4,5

© 2019 Designs for Health Pty Ltd FOR PROFESSIONAL REFERENCE ONLY designsforhealth.com.au Vitamin D Supreme™ Supports replenishment and restoration of Vitamin D levels and Calcium absorption

The Importance of Vitamin D cont. Vitamin D has also been found to have a positive effect on immune function, with scientists contributing vitamin D deficiency to the development of several immune mediated conditions such as multiple sclerosis, Diabetes and other auto immune conditions. Vitamin D has also proven effective at boosting the immune system in acute infections such as influenza.2,3 How does vitamin K help the bones? Osteocalcin is the most well-known Gla (γ-carboxyglutamic acid) protein. It has been widely recognized for its importance in bone density and requires vitamin K to work properly. Vitamin K is necessary for the carboxylation (the addition of a carboxyl group) of osteocalcin. Undercarboxylated osteocalcin cannot regulate calcium, and thus, increases the risk of calcium being deposited in areas where it should not be (arteries and soft tissue).7,8,11 Background: The inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known, particularly within ranges comparable to the probable physiologic supply of the vitamin. Objectives: The objectives were to establish the quantitative relation between steady state cholecalciferol input and the resulting serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores. Design: Vitamin D3 (Cholecalciferol) was administered daily in controlled oral doses labelled at 0,25 μg (1,000 IU), 125 μg (6,000 IU), and 250 μg (10,000 IU) cholecalciferol for approximately 20 weeks during the winter to 67 men living in Omaha (41.2 degrees N latitude). The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment. Results: From a mean baseline value of 70.3 nmol/L, equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose, with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input. The calculated oral input required to sustain the serum 25-hydroxycholecalcifero concentration present before the study (i.e. in the autumn) was 12.5 micro g (500 IU)/d, whereas the total amount from all sources (supplement, food, tissue stores) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g (approximately 3800 IU)/d. By difference, the tissue stores provided approximately 78-82 micro g/d. Conclusions: Healthy men seem to use 3000-5000 IU cholecalciferol/d, apparently meeting > 80% of their winter cholecalciferol need with cutaneously synthesised accumulations from solar sources during the preceding summer months. Current recommended vitamin D inputs are inadequate to maintain serum 25-hydroxycholecalciferol concentration in the absence of substantial cutaneous production of vitamin D. Figure 1. Time course of serum 25-hydroxycholecalciferol [25(OH)D] concentration for the 4 dosage groups. The points represent the mean values, and error bars are 1 SEM. The curves are the plot of Equation 1, fitted to the mean 25(OH)D3 values for each dosage group. The curves, from the lowest upward, are for 0,25 μg (1,000 IU), 125 μg (6,000 IU), and 250 μg (10,000 IU) μg cholecalciferol (labelled dose)/d. The horizontal dashed line reflects zero change from baseline.

10,000 IU

6,000 IU

1,000 IU Placebo Note: that 10,000 IUs of D3 is the maximum daily amount made by the skin in response to sun exposure, full body for 20 mins., between 11am-2pm, at latitudes lower than 40 degrees.

© 2019 Designs for Health Pty Ltd FOR PROFESSIONAL REFERENCE ONLY designsforhealth.com.au Vitamin D Supreme™ Supports replenishment and restoration of Vitamin D levels and Calcium absorption

ACTIVE INGREDIENTS PER CAPSULE: EXCIPIENT INGREDIENTS PER CAPSULE:

Colecalciferol (Vit D) 25 micrograms - Microcrystalline cellulose - Corn starch Equiv to 1000IU - Leucine - Bovine gelatin hydrolyzed - Hypromellose - Sucrose Menaquinone 7 (Vit K2) 50 micrograms - Purified water - D-l-alpha - Beeswax yellow - Silicon dioxide Phytomenadione (Vit K1) 500 micrograms - Candelilla wax

DOES NOT CONTAIN THE FOLLOWING: PACK SIZE:

Gluten, dairy, lactose, seeds or nuts. 60 per bottle.

DIRECTIONS FOR USE:

Take 1 capsule per day, or as directed by your healthcare professional.

Designed, encapsulated & packed in Australia from local and imported ingredients.

PRESCRIBING INFORMATION: > Mineral oil, orlistat or lowering drugs such as cholestyramine may affect absorption of fat-soluble vitamins including vitamin D. > Vitamin D may reduce the effectiveness of calcium channel blockers, caution is advised with concurrent use. > Concomitant use of vitamin D with aluminium may potentially increase aluminium absorption. > Evidence does not indicate that pregnant women should be provided with supplemental vitamin K, unless under supervision. > Vitamin K may adversely interact with anticoagulant medications such as , patients taking these medications should seek medical advice before taking Vitamin D Supreme.

FURTHER SUGGESTIONS FOR THERAPEUTIC USE: Immune health: Vitamin D is considered an immune system modulator consider using Vitamin D Supreme where extra immune support is required. Cardiovascular health: Vitamin D is required for cardiac cell growth and is also involved in normal cardiac rhythm, blood pressure, vascular tone and tissue maturation. Prostate health: Vitamin D receptors are present in prostate tissue and are involved in prostate cell metabolism and maturation.

WARNINGS: > If symptoms persist consult your healthcare practitioner. > Vitamins and minerals must not replace a balanced diet.

HIGHLIGHTED PROPRIETARY/SPECIAL INGREDIENTS:

© 2019 Designs for Health Pty Ltd FOR PROFESSIONAL REFERENCE ONLY designsforhealth.com.au Vitamin D Supreme™ Supports replenishment and restoration of Vitamin D levels and Calcium absorption

REFERENCES 1. Braun and Cohen. Herbs & Natural Supplements. An Evidence-Based guide 4th Ed. Elevier. 2. PDR for Nutritional Supplements 1st Ed., Medical Economics Co., Montvale, New Jersey, 2001. 3. Pizzorno JE, Murray MT. Textbook of Natural Medicine (2nd Ed.), Churchill Livingstone, New York, 1999. 4. Effect of vitamin K in bone metabolism and vascular calcification: A review of mechanisms of action and evidences. Villa JKD, Diaz MAN, Pizziolo VR, Martino HSD, Crit Rev Food Sci Nutr. 2017 Dec 12;57(18):3959-3970. 5. Vitamin K: from to calcification., Paakkari I. Duodecim. 2016;132(19):1755-62. Review. 6. Vitamin K-containing dietary supplements: comparison of synthetic vitamin K1 and natto-derived menaquinone-7. Schurgers LJ, Teunissen KJ, Hamulyák K, Knapen MH, Vik H, Vermeer C.Blood. 2007 Apr 15;109(8):3279-83. Epub 2006 Dec 7. 7. Vitamin K and bone health. Hamidi MS, Gajic-Veljanoski O, Cheung AM. J Clin Densitom. 2013 Oct-Dec;16(4):409-1. 8. Vitamin K and bone health. Weber P. Nutrition. 2001 Oct;17(10):880-7. Review. Erratum in: Nutrition 2001 Nov-Dec;17. 9. Vitamin K1 supplementation retards bone loss in postmenopausal women between 50 and 60 years of age. Braam LA, Knapen MH, Geusens P, Brouns F, Hamulyák K, Gerichhausen MJ, Vermeer C. Calcif Tissue Int. 2003 Jul. 10. Vitamins D and K as pleiotropic nutrients: clinical importance to the skeletal and cardiovascular systems and preliminary evidence for synergy. Kidd PM. Altern Med Rev. 2010 Sep;15(3):199-222. 11. Low-Dose Daily Intake of Vitamin K(2) (Menaquinone-7) Improves Osteocalcin γ-Carboxylation: A Double-Blind, Randomized Controlled Trials. Inaba N, Sato T, Yamashita T. J Nutr Sci Vitaminol (Tokyo). 2015;61(6):471-8. 12. Vitamin D: skeletal and muscular effects. Thomas T, Briot K., Presse Med. 2013 Oct;42(10):1351-7. 13. Current Topics on Vitamin D. The role of active forms of vitamin D in regulation of bone remodeling. Nakamichi Y, Takahashi N. Clin Calcium. 2015 Mar;25(3):395-40. 14. Vitamin D insufficiency, deficiency, and bone health. Gallagher JC, Sai AJ.J Clin Endocrinol Metab. 2010 Jun;95(6):2630-3.

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