To Treat or Not to Treat Vitamin D Deficiency
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1 To Treat or Not to Treat Vitamin D Deficiency C. W. Spellman, DO, PhD, FACOI Professor and Associate Dean Research Dir. Center Diabetes and Metabolic Disorders Department Internal Medicine, Div. Endocrinology Texas Tech University Health Science Center-PB Midland-Odessa, Texas
2 Agenda 1. What s in a name? 2. What are normal Vit D levels? l (You might be surprised) 3. What are the consequences of low Vit D? 4. Should everyone be tested t for low vit D? 5. How should I treat low levels of vit D? Which Rx? How much? What schedule? How long? Re-test?
3 Doctor, you said to take some vit Doctor, you said to take some vit D but I can t figure out what to buy or what any of the names mean
4 Vitamin D Precursors There are 2 parent forms of vit D called D2 and D3 D2 is an oral supplement derived from the plant sterol ergosterol and is a 28 carbon structure D3 is synthesized in the skin after exposure to UV radiation of endogenous 7-dehydrocholesterol, a 27 carbon structure D2 d D3 t ll it i d b th b D2 and D3 are actually pro-vitamins and both can be converted to biologically active vit D
5 Activation of Pro-Vitamin D2 and D3 Vit D2 and D3 have no biologic activity and must be modified by 2 hydroxylation reactions Step 1 is addition of an OH group at carbon 25 and this happens in the liver to yield 25(OH)D i.e. 25(OH)D2 or 25(OH)D3 Step 2 is addition i of an OH group at carbon 1 and this occurs in the proximal tubules of the kidney to yield metabolically active 1-25(OH) 2 D i.e. 1-25(OH) 2 D2 or 1-25(OH) 2 D3 Note: 1-25(OH)D is also produced in many other tissues: Note: 1-25(OH)D is also produced in many other tissues: Pancreas, brain, lymph node, heart, gut, adrenals, prostate etc.
6 Vitamin D Terminology The term Vit D is confusing because it may be used as a general term to refer to any of the forms of vit D The pro-vitamin D2 is called ergocalciferol The pro-vitamin D3 is called cholecalciferol Sometimes, D2 and D3 are referred to as Calciferal 25(OH)D2 and 25(OH)D3 are called calcefediol 1-25(OH) 2 D2 and 1-25(OH) 2 D3, the active forms of vit D, are called calcitriol
7 Basic Physiology of Calcium, PTH, Vit D Ca PO 4 PTH PTH PTH renal 1-hydroxylase y 1,25 vit D calcium resorption from bone and by kidney 1,25 Vit D Calcium absorption o from gut PTH renal 1-hydroxylase renal l24hd 24-hydroxylase (switch to inactive 24-25(OH) 25(OH) 2 D3) Fibroblast growth factor 23 renal 1-hydroxylase PO 4 ( excretion)
8 Requesting Lab for Vitamin D Levels Order 1-25 (OH)D to determine if vit D is high Order 25(OH)D to determine if vit D is low Why? Because [25(OH)D] ~1000x > [1-25(OH) 2 D] Note: Lab must report total t 25(OH)D Total 25(OH)D = 25(OH)D2 + 25(OH)D3 So what? In humans >99% is D3, but; if the person is on D2 therapy, ~55% is D2 and ~45% is D3
9 What are Normal Vitamin D Levels? What the cut points that define vit D levels Normal ng/ml 1 Insufficient 10- <32 2 Deficient <10 2 A normal level of vit D is based on measurements in sun exposed individuals 50-75% of population have levels <30 ng/ml 20-35% have levels <20 ng/ml Hollis BW, Wagner CL. NEJM 2005;352: Heaney RP. Am J Clin Nutr 2004;80(suppl):1706S 3. Holick MF et al. J Clin Endocrinol Metab 2005;90: Ginde AA et al. Arch Intern Med 2009;169: Orwoll E et al. J Clin Endocrinol Metab 2009;94:1214
10 What Are the Consequences of fl Low Vitamin i D? Bone Rickets has been known for centuries and is associated with vit D levels <10 ng/ml 1 Low vit D ~20 ng/ml is associated with hip fractures 2 Vit D3 (min dose 800 U/d) reduces fractures ~20% 3.4 Muscle Muscle pain and weakness is due to atrophy of type II (fast twitch) fibers 5,6 and is associated with vit D levels <20 ng/ml 7 Vit D (min dose 800 U/d) reduces risk of falls ~70% 8 Vit D levels in those at highest risk <16 ng/ml 9
11 What Are the Consequences of fl Low Vitamin i D? Cancer Vit D is anti-proliferative, pro-differentiating 10,11 Epidemiology studies suggest that higher vit D levels are associated with lower incidence of many cancers and better survival if neoplasia occurs Associations between vit D and cancer 15,16 >20 ng/ml 30-50% colorectal, prostate cancer >50 ng/ml 50% breast cancer Early clinical trials are in progress evaluating the anti-tumor tumor effects of vit D and new D analogs 17
12 Kidney What Are the Consequences of fl Low Vitamin i D? In CKD, PO 4 and PTH are universal which leads to mineral-bone disease and calcium deposition in the vasculature, i.e. atherosclerosis 18,19 85% of CKD patients have low vit D due to i. Decreased renal mass GFR delivery 25(OH)D to 1- -hydroxlyase 20 ii. PO 4 retention induces FGF-23 whose activity is >PTH 1- -hydroxlyase 21 Heart Vit D deficient adults have 50% risk of MI 22 Vit D may BP and LVH by RAAS activity 23
13 What Are the Consequences of fl Low Vitamin i D? Diabetes vit D PTH Ca lipolysis (FFA) insulin resistance and insulin release 24,25 Prevalence of Metabolic Syndrome Components 26 Vit D Level <20 ng/ml >40 ng/ml Metabolic Synd 28% 13% Abd Obesity 50% 19% TG 30% 24% HDL 40% 30% BP 15% 6% Glucose 34% 24%
14 References, Consequences of Low Vitamin D 1. Heaney RP. Am J Clin Nutr 2004;80(suppl):1706S 2 Cauley JA, et al. Ann Intern Med 2008;149:242 3 Bischoff-Ferrari i HA et al. JAMA 2005;293: Bischoff-Ferrari HA et al. Arch Intern Med 2009;169:551 5 Glerup H et al. Calcif Tissue Int 2000;66:419 6 Flicker L J Am Geriatr Soc 2003;51: Binkley N. J Musculoskelet l Neuronal Interact t 2006;6: Broe KE et al. J Am Geriatr Soc 2007;55:243 9 Bischoff-Ferrari HA et al. Am J Clin Nutr 2006;84:18 10 No benefit: Wactawski-Wende J et al. Women Health Initiative NEJM 2006;354: Positive benefit clinicaltrials.gov i lt i l as NCT Wei MY et al. Cancer Epidemiol Biomarkers Prev 2008;17(11): Yin L, et al. Aliment Pharmacol Ther 2009;30(2): Ng K, et al. J Clin Oncol 2008;26(18): Ahonen MH, et al.cancer Causes Control 2000;11(9): Garland CF, et al. Lancet 1989;2(8673): Vitamin D. Endocrin Metab Clin N Amer 2010;39(2): National Kidney Foundation. Am J Kidney Dis 2003;42:S1 19. Blacher J et al. Hypertension 2001;38(4): LaClair RE et al. Am J Kidney Dis 2005;45(6): Shimada T et al. J Bone Miner Res 2004;19(3): Wang TJ, et al. Circulation 2008;117(4): Clinicaltrials.gov i lt i l NCT and NCT Guillausseau PJ, et al. Diabetes Metab 2008;34(suppl 2):S Chiu KC et al. Am J Clin Nutr 2004;79(5): Ford ES, et al. Diabetes Care 2005;28(5):1228
15 Should Everyone be Screened to Determine Vit D Levels? No current recommendations to screen everyone, however, this may change in the near future There is evidence to support screening at-risk people: Osteoporosis Malabsorption (bariatric surgery, Celiac, etc) Hepatic disease Renal disease Patients on anti-seizure drugs Cancer patients (?) Unknown: Crohn s, TB, MS, T1D, T2D, CAD
16 Treating Vit D Insufficiency Goals Estimates are based vit D levels where PTH begins increasing, bone density decreases, eases, rates of gut calcium absorption and kinetics of D2 or D3 hydroxylation Normal range for vit D is ng/ml 1 32 ng/ml is accepted as the minimum level 2 Optimum level =? 1. Hollis BW. Endocrinol Metab Clin N Amer 2010;39(2): Hollis BW, Wagner CL. NEJM 2005;352:515
17 Preventing Vit D Insufficiency Major source of vit D is sun exposure 1 Minimum sun exposure for 20, units vit D: 2 hour/wk light skin persons hour/wk dark skin persons 3 However, life styles world wide have minimized sun exposure to the extent that no variations in vit D levels are now seen in different latitudes 4 Note: Diet is a poor source of vit D 5 1. Holick MF. Am J Clin Nutr 2004;80(6 suppl):1678s 2. Specker BL et al. J Pediatr 1985;107(3): Clemens TL et al. Lancet 1982;1(8263):74 4. Kimlin MG Mol Aspects Med 2008;29(6): Calvo MS, Whiting SJ. Nutr Rev 2003;61:107
18 Preventing Vit D Insufficiency Over-the-counter-supplements? Good luck potency is unknown, regardless of what the label says Dose No consensus on dose for different ages or ethnic groups 1,2 Best estimates Natl Osteoporosis Foundation: U/d 3 Expert opinion 2000 U/day 4 Pregnancy 2000 U/d minimum 5 1. MacLaughlin JA, et al. J Clin Invest 1985;76: Weaver CM et al. Am J Clin Nutr 2004;80:1735S 3. Natl Osteoporosis Foundation Heaney RP. J Nutr 2006;136: Binkley N et al. Endocrinol Metab Clin N Amer 2010;39(2):277
19 Rx for Vit D Insufficiency-Deficiency Available vit D Rx D2 ergocalciferol 50,000 U 8,000 U/mL D3 cholecalciferol 5,000, 2000, 1000, 400 U 1-25(OH)D3 calcitriol 0.25, 0.5 mcg Rocaltrol 0.25, 0.5 mcg Calcijex 0.5 mcg (IV) Use D2 or D3 for insufficiency or deficiency: Safe! Use 1-25(OH)D in ESRD Caution: Hypercalcemia Note: The analogs doxercalciferal and paricalcitol are only approved for SHPT in CKD III-V
20 Treating Vit D Insufficiency Seru m 25(OH) )D ng/ml Response to therapy is variable 1 (1600 U vit D per day) Months 1. Binkley N et al. J Bone Miner Res 2008;23(suppl 1):S350
21 Treating Vit D Insufficiency-Deficiency Which oral supplement is best, D2 or D3? Most studies indicate that D3 is more potent than D2. 1 Some studies demonstrate t D2 = D3 2 Currently D2 and D3 are regarded as clinically interchangeable for treating insufficiency or deficiency Only high dose form of pro-vit D is ergocalciferol 1. Armas LAG et al. J Clin Endocrinol Metab 2004;89: Holick MF et al. J Clin Endocrinol Metab 2008;93:677
22 Treating Vit D Insufficiency-Deficiency Vit D regimens No consensus on best protocol Ergocalciferol: 50, U, 2 days/month 50,000 U, 5 days/month 50,000 U, 1 dose/week 50,000 U, 2 doses/week 50,000 U, 3 doses/week? Cholecalciferol: 1,000 U, daily 5,000 U, daily
23 Treating Vit D Insufficiency-Deficiency Perspectives 600, U of D2 over 2 months will increase 25(OH)D levels to >30 ng/ml in 65% of patients 1 50, U of D2 per week up to 3 years will increase 25(OH)D levels to >30 ng/ml in ~100% of patients 2 Rule of thumb: 1000 U D3 daily will 25(OH)D levels by 10 ng/ml 3 Note: 50,000 U D2 sounds like a big dose, but know that 50,000 U = 1.25 mg 1. Pepper KJ et al. Endocr Pract 2009;15:95 2. Ramamurthy R et al. J Clin Densitom 2009;12: Binkley N. J Bone Miner Res 2008;23(suppl 1)S350
24 Vit D Toxicity There is no cut-point defining what level of 25(OH)D should be considered d toxic 1 Some labs use >80 ng/ml as a toxic level Some labs use >100 ng/ml as a toxic level Review of all reports of hypercalcemia due to vit D toxicity report 25(OH)D levels >88 ng/ml The maximum level of 25(OH)D attained from sun exposure is ng/ml 2,3 1. Vieth R. J Bone Miner Res 2007;22(suppl 2):V64 2. Binkley N et al. J Clin Endocrinol Metab 2007;92: Barger-Lux MJ, Heaney RP. J Clin Endocrinol Metab 2002;87:4952
25 Monitoring Vit D Therapy Best way to monitor therapy is not established Recommendation 1 Check 25(OH)D levels 4-6 months in high-risk patients (osteomalacia, fragility fractures, high-risk falls) Rationale is that it requires 3-6 months for serum 25(OH)D levels to plateau after starting therapy Binkley N. Endocrinol Metab Clin N Amer 2010;39(2):287
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