Safety of Vitamin D. Reinhold Vieth
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1 Safety of Vitamin D Reinhold Vieth Professor, Departments of Nutritional Sciences and Laboratory Medicine and Pathobiology, University of Toronto, and Pathology, Mount Sinai Hospital, Toronto safety 1: the condition of being safe from undergoing or causing hurt, injury, or loss IOM August
2 Safety = Toxicity For vitamin D, the classic criteria for harm pertain to excessive calcium in serum or urine. No other harmful outcomes are known except for some epidemiologic relationships that relate higher serum 25(OH)D to higher risk of prostate and pancreatic cancers.
3 Safety = Toxicity The context of calcium excess:
4 Vitamin D3 Poisoning by Table Sugar. DOSE: 1.7 MILLION UNITS/DAY FOR 7 MONTHS! Reinhold Vieth PhD b, Tanya R Pinto BSc b, Bajinder S Reen MD a, and Min M Wong MD a Lancet : 672 June 1999, a 29-year-old man admitted to emergency with symptoms of: extreme right-sided flank pain conjunctivitis (a sign of dehydration) increased thirst vomiting in acute renal failure anorexia fever, chills Initially treated with steroids and discharged: presumed gastroenteritis
5 Vitamin D3 Poisoning by Table Sugar. DOSE: 1.7 MILLION UNITS/DAY FOR 7 MONTHS! October 1999, his 63-year-old father was admitted to emergency with similar complaints. He was also in acute renal failure, and no history of stones. Calcium VERY HIGH 3.82 mmol/l (normal, mmol/l), 25(OH)D HIGH 1555 nmol/l (normal nmol/l) 1,25(OH) 2 D NEAR NORMAL 151 pmol/l (normal, pmol/l Elevated free 1,25(OH)2D causing toxicity. Lancet : 672
6 Vitamin D3 Poisoning by Table Sugar. Vit D DOSE: 1.7 MILLION UNITS/DAY FOR 7 MONTHS! October 1999, his 63-year-old father was admitted to emergency with similar complaints. He was also in acute renal failure, and no history of stones. Calcium VERY HIGH 3.82 mmol/l (normal, mmol/l), 25(OH)D HIGH 1555 nmol/l (normal nmol/l) 1,25(OH) 2 D NEAR NORMAL 151 pmol/l (normal, pmol/l Elevated free 1,25(OH)2D causing toxicity. Lancet : 672
7 2. Saturability: 25(OH)D > 600 nmol/l Log Scale Values of the units in the graph FREE 1,25(OH)2D fmol/l Total 1,25(OH)2D pmol/l Plasma Calcium mg/dl Percent of 1,25(OH)2D that is FREE in plasma ng/ml Plasma 25(OH)D nmol/l Calcium 1,25(OH)2D free %FREE Toxic mechanism involves FREE 1,25(OH)2D Pettifor, J. M. et. al. Ann Inter Med 1995;122:
8 SATURABILITY OF DBP PLASMA D-Binding Protein (capacity 4300 nmol/l 1800 ng/ml) PLASMA VITAMIN D METABOLITES BOUND PLASMA 1,25(OH)2D BOUND Vieth Bone and Mineral, 11 (1990) PLASMA 1,25(OH)2D FREE Excessive calcium in blood and urine INTESTINE CALCIUM ABSORPTION BONE CALCIUM RESORPTION
9 Human Dose Response for vitamin D Serum 25(OH)D nmol/l x Vitamin D Intake IU/day 4000 Study Group Mean Data Vit D2-Treated Group Mean Data Individuals with Vit D2 Hypercalcemia 20 UL 40, , Data from literature cited in Vieth 1999, Amer J Clin Nutr,69:842 Hathcock JN, Shao A, Vieth R, Heaney R. Am J Clin Nutrition 2007 TANNING X X X X X X X X X X XX X X = reported toxicity = HYPERCALCEMIA Vitamin D µg/day X Serum 25(OH)D ng/ml
10 Am J Clin Nutr 2007;86:
11 Doses of vitamin D pertinent to the UL and LOAEL, and their effects on serum calcium MS Patients on 1200 mc Ca. EVERY MONTH THE VITAMIN D3 DOSE WAS INCREASED IN A STUDY TO CHARACTERIZE TOLERABILITY TO SPECIFIC SERUM 25(OH)D LEVEL 800 Kimbal et al Am J Clin Nutr 2007;86: Serum 25(OH)D (nmol/l) Serum 25(OH)D ng/ml Baseline Calcium ,000 Vitamin D3 Dose Schedule (ug/d)
12 1.00 Urine alcium: eatinine ratio Baseline 100 Calcium ,000 Vitamin D3 Dose Schedule (ug/d) 2.4 Serum Calcium mmol/l) (OH)D ng/m Baseline Calcium ,000 Vitamin D3 Dosing Schedule (ug/d) Kimbal et al Am J Clin Nutr 2007;86:
13 ABSORPTION OF CALCIUM FROM DIET? The effect of vitamin D nutrition (based on serum 25(OH)D reaches a plateau at about 80 nmol/l) 32 ng/ml R Heaney, Journal of Steroid Biochemistry & Molecular Biology xxx(2005)
14 Urine calcium / creatinine ratio vs 25(OH)D Urine Calcium/Creatinine mg/mg Range to which vitamin D helps increase calcium absorption Range of no effect on Ca absorption First evidence that higher 25(OH)D is driving Ca absorption. Thi is NOT YET TOXIC NG/ML Serum 25(OH)D nmol/l (LOG SCALE)
15 Safety = Toxicity The context of Higher 25(OH)D and Higher Cancer risk
16 Overall conclusion 6: adverse events There is no data available on the health hazards of long term maintenance of high 25 hydroxyvitamin D serum levels in healthy subjects over long periods. Past experiences with other compounds (e.g., several anti oxidants and hormone replacement therapies) have shown serious adverse effects of the chronic use of supplements or long term maintenance of high serum levels. Pg 30
17 Evidence Report/Technology Assessment Number 183 Vitamin D and Calcium: A Systematic Review of Health Outcomes Prepared for: Agency for Healthcare Research and Quality
18 Evidence Report/Technology Assessment Number 183 Vitamin D an Calcium: A Systematic Review of Health Outcome Prepared for: Agency for Healthcare Research and Quali 3.5 Odds Ratio vs Quartile >66 Serum 25(OH)D nmol/l Stolzenberg-Solomon 2006
19 Evidence Report/Technology Assessment Number 183 Vitamin D and Calcium: A Systematic Review of Health Outcomes Prepared for: Agency for Healthcare Research and Quality Odds ratio Low UV P=0.015 High UV 0 Stolzenberg-Solomon 2009 < >78 Serum 25(OH)D nmol/l
20 SAME AVERAGE 25(OH)D BUT Larger amplitude results in larger below-setpoint phase in tissue 1,25(OH)2D Serum 25(OH)D and Tissue 1,25(OH)2D (OH)D Tissue 1,25(OH)2D Setpoint Shaded area highlights the subsetpoint phases in tissue 1,25(OH)2D. Serum 25(OH)D and Tissue 1,25(OH)2D Days A 25(OH)D Tissue 1,25(OH)2D Setpoint Days Days Vieth 2009 Anticancer Research, In Press
21 Higher 25(OH)D would dampen negative effects of seasonal variation: Shaded area highlights the subsetpoint phases in tissue 1,25(OH)2D. Serum 25(OH)D and Tissue 1,25(OH)2D (OH)D Days Tissue 1,25(OH)2D Setpoint Serum 25(OH)D and Tissue 1,25(OH)2D (OH)D Tissue 1,25(OH)2D Setpoint Days Vieth 2009 Anticancer Research, In Press
22 Safety = Toxicity For vitamin D, the classic criteria for harm pertain to excessive calcium in serum or urine. TOXICITY REQUIRES AVERAGE DAILY INTAKES WELL BEYOND 10,000 IU Northern or low-uv environments: epidemiologic relationships with higher serum 25(OH)D and higher risk of prostate and pancreatic cancers. These may be due to seasonal high/low fluctuations in 25(OH)D that may be alleviated with vitamin D supplementation.
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