| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Original Research Communication |
1 From the Department of Pathology and Laboratory Medicine, the University of Toronto and Mount Sinai Hospital, Toronto, Canada, and DiaSorin Inc, Stillwater, MN.
Background: The Food and Nutrition Board of the National Academy of Sciences states that 95 µg vitamin D/d is the lowest observed adverse effect level (LOAEL).
Objective: Our objective was to assess the efficacy and safety of prolonged vitamin D3 intakes of 25 and 100 µg (1000 and 4000 IU)/d. Efficacy was based on the lowest serum 25-hydroxyvitamin D [25(OH)D] concentration achieved by subjects taking vitamin D3; potential toxicity was monitored by measuring serum calcium concentrations and by calculating urinary calcium-creatinine ratios.
Design: Healthy men and women (n = 61) aged 41 ± 9 y (
± SD) were randomly assigned to receive either 25 or 100 µg vitamin D3/d for 2–5 mo, starting between January and February. Serum 25(OH)D was measured by radioimmunoassay.
Results: Baseline serum 25(OH)D was 40.7 ± 15.4 nmol/L ( ± SD). From 3 mo on, serum 25(OH)D plateaued at 68.7 ± 16.9 nmol/L in the 25-µg/d group and at 96.4 ± 14.6 nmol/L in the 100-µg/d group. Summertime serum 25(OH)D concentrations in 25 comparable subjects not taking vitamin D3 were 46.7 ± 17.8 nmol/L. The minimum and maximum plateau serum 25(OH)D concentrations in subjects taking 25 and 100 µg vitamin D3/d were 40 and 100 nmol/L and 69 and 125 nmol/L, respectively. Serum calcium and urinary calcium excretion did not change significantly at either dosage during the study.
Conclusions: The 100-µg/d dosage of vitamin D3 effectively increased 25(OH)D to high-normal concentrations in practically all adults and serum 25(OH)D remained within the physiologic range; therefore, we consider 100 µg vitamin D3/d to be a safe intake.
Key Words: Cholecalciferol • calcidiol • vitamin D3 • hypercalciuria • toxicity • lowest observed adverse effect level • LOAEL • efficacy
This article has been cited by other articles:
|
|
 |
|
  J. N. Hathcock and A. Shao Expanded Approach to Tolerable Upper Intake Guidelines for Nutrients and Bioactive Substances J. Nutr., October 1, 2008; 138(10): 1992S - 1995S. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Scragg and C. A. Camargo Jr. Frequency of Leisure-Time Physical Activity and Serum 25-Hydroxyvitamin D Levels in the US Population: Results from the Third National Health and Nutrition Examination Survey Am. J. Epidemiol., September 15, 2008; 168(6): 577 - 586. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Ish-Shalom, E. Segal, T. Salganik, B. Raz, I. L. Bromberg, and R. Vieth Comparison of Daily, Weekly, and Monthly Vitamin D3 in Ethanol Dosing Protocols for Two Months in Elderly Hip Fracture Patients J. Clin. Endocrinol. Metab., September 1, 2008; 93(9): 3430 - 3435. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S.-M. Orton, A. P Morris, B. M Herrera, S. V Ramagopalan, M. R Lincoln, M. J Chao, R. Vieth, A D. Sadovnick, and G. C Ebers Evidence for genetic regulation of vitamin D status in twins with multiple sclerosis Am. J. Clinical Nutrition, August 1, 2008; 88(2): 441 - 447. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Maalouf, M. Nabulsi, R. Vieth, S. Kimball, R. El-Rassi, Z. Mahfoud, and G. El-Hajj Fuleihan Short- and Long-Term Safety of Weekly High-Dose Vitamin D3 Supplementation in School Children J. Clin. Endocrinol. Metab., July 1, 2008; 93(7): 2693 - 2701. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Wagner, G. Sidhom, S. J. Whiting, D. Rousseau, and R. Vieth The Bioavailability of Vitamin D from Fortified Cheeses and Supplements Is Equivalent in Adults J. Nutr., July 1, 2008; 138(7): 1365 - 1371. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. R. Ebeling Osteoporosis in Men N. Engl. J. Med., April 3, 2008; 358(14): 1474 - 1482. [Full Text] [PDF]
|
|
|
|
|
|
S. A Talwar, J. F Aloia, S. Pollack, and J. K Yeh Dose response to vitamin D supplementation among postmenopausal African American women Am. J. Clinical Nutrition, December 1, 2007; 86(6): 1657 - 1662. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. Dawson-Hughes, P. Chen, and J. H. Krege Response to Teriparatide in Patients with Baseline 25-Hydroxyvitamin D Insufficiency or Sufficiency J. Clin. Endocrinol. Metab., December 1, 2007; 92(12): 4630 - 4636. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. T. Alpert and U. Shaikh The Effects of Vitamin D Deficiency and Insufficiency on the Endocrine and Paracrine Systems Biol Res Nurs, October 1, 2007; 9(2): 117 - 129. [Abstract] [PDF]
|
|
|
|
|
|
S. M Kimball, M. R Ursell, P. O'Connor, and R. Vieth Safety of vitamin D3 in adults with multiple sclerosis Am. J. Clinical Nutrition, September 1, 2007; 86(3): 645 - 651. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
Y. Manios, G. Moschonis, G. Trovas, and G. P Lyritis Changes in biochemical indexes of bone metabolism and bone mineral density after a 12-mo dietary intervention program: the Postmenopausal Health Study Am. J. Clinical Nutrition, September 1, 2007; 86(3): 781 - 789. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Dawodu and C. L Wagner Mother-child vitamin D deficiency: an international perspective Arch. Dis. Child., September 1, 2007; 92(9): 737 - 740. [Full Text] [PDF]
|
|
|
|
|
|
H. F Saadi, A. Dawodu, B. O Afandi, R. Zayed, S. Benedict, and N. Nagelkerke Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women Am. J. Clinical Nutrition, June 1, 2007; 85(6): 1565 - 1571. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. Schwalfenberg Not enough vitamin D: Health consequences for Canadians Can Fam Physician, May 1, 2007; 53(5): 841 - 854. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. N Hathcock, A. Shao, R. Vieth, and R. Heaney Risk assessment for vitamin D Am. J. Clinical Nutrition, January 1, 2007; 85(1): 6 - 18. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. A. Mikati, L. Dib, B. Yamout, R. Sawaya, A. C. Rahi, and G. E.-H. Fuleihan Two randomized vitamin D trials in ambulatory patients on anticonvulsants: Impact on bone Neurology, December 12, 2006; 67(11): 2005 - 2014. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. A Houghton and R. Vieth The case against ergocalciferol (vitamin D2) as a vitamin supplement. Am. J. Clinical Nutrition, October 1, 2006; 84(4): 694 - 697. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. T. Viljakainen, A. Palssa, M. Karkkainen, J. Jakobsen, and C. Lamberg-Allardt How much vitamin d3 do the elderly need? J. Am. Coll. Nutr., October 1, 2006; 25(5): 429 - 435. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. A Bischoff-Ferrari, E. Giovannucci, W. C Willett, T. Dietrich, and B. Dawson-Hughes Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes Am. J. Clinical Nutrition, July 1, 2006; 84(1): 18 - 28. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. F. McCarty and K. I. Block Toward a core nutraceutical program for cancer management. Integr Cancer Ther, June 1, 2006; 5(2): 150 - 171. [Abstract] [PDF]
|
|
|
|
 |
|
 B. W. Hollis and C. L. Wagner Nutritional vitamin D status during pregnancy: reasons for concern. Can. Med. Assoc. J., April 25, 2006; 174(9): 1287 - 1290. [Full Text] [PDF]
|
|
|
|
|
|
R. Vieth Critique of the Considerations for Establishing the Tolerable Upper Intake Level for Vitamin D: Critical Need for Revision Upwards J. Nutr., April 1, 2006; 136(4): 1117 - 1122. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
G. El-Hajj Fuleihan, M. Nabulsi, H. Tamim, J. Maalouf, M. Salamoun, H. Khalife, M. Choucair, A. Arabi, and R. Vieth Effect of Vitamin D Replacement on Musculoskeletal Parameters in School Children: A Randomized Controlled Trial J. Clin. Endocrinol. Metab., February 1, 2006; 91(2): 405 - 412. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. F. Garland, F. C. Garland, E. D. Gorham, M. Lipkin, H. Newmark, S. B. Mohr, and M. F. Holick The Role of Vitamin D in Cancer Prevention Am J Public Health, February 1, 2006; 96(2): 252 - 261. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. Steingrimsdottir, O. Gunnarsson, O. S. Indridason, L. Franzson, and G. Sigurdsson Relationship Between Serum Parathyroid Hormone Levels, Vitamin D Sufficiency, and Calcium Intake JAMA, November 9, 2005; 294(18): 2336 - 2341. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. M. Spach and C. E. Hayes Vitamin D3 Confers Protection from Autoimmune Encephalomyelitis Only in Female Mice J. Immunol., September 15, 2005; 175(6): 4119 - 4126. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. F. Aloia, S. A. Talwar, S. Pollack, and J. Yeh A Randomized Controlled Trial of Vitamin D3 Supplementation in African American Women Arch Intern Med, July 25, 2005; 165(14): 1618 - 1623. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Vasquez and J. Cannell Calcium and vitamin D in preventing fractures: Data are not sufficient to show inefficacy BMJ, July 9, 2005; 331(7508): 108 - 109. [Full Text]
|
|
|
|
 |
|
 J. L. Johnson, V. V. Mistry, M. D. Vukovich, T. Hogie-Lorenzen, B. W. Hollis, and B. L. Specker Bioavailability of Vitamin D from Fortified Process Cheese and Effects on Vitamin D Status in the Elderly J Dairy Sci, July 1, 2005; 88(7): 2295 - 2301. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. A. Bischoff-Ferrari, W. C. Willett, J. B. Wong, E. Giovannucci, T. Dietrich, and B. Dawson-Hughes Fracture Prevention With Vitamin D Supplementation: A Meta-analysis of Randomized Controlled Trials JAMA, May 11, 2005; 293(18): 2257 - 2264. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Goussous, L. Song, G. E. Dallal, and B. Dawson-Hughes Lack of Effect of Calcium Intake on the 25-Hydroxyvitamin D Response to Oral Vitamin D3 J. Clin. Endocrinol. Metab., February 1, 2005; 90(2): 707 - 711. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. J. Whiting and M. S. Calvo Dietary Recommendations for Vitamin D: a Critical Need for Functional End Points to Establish an Estimated Average Requirement J. Nutr., February 1, 2005; 135(2): 304 - 309. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. W. Hollis Circulating 25-Hydroxyvitamin D Levels Indicative of Vitamin D Sufficiency: Implications for Establishing a New Effective Dietary Intake Recommendation for Vitamin D J. Nutr., February 1, 2005; 135(2): 317 - 322. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. M Weaver and J. C Fleet Vitamin D requirements: current and future Am. J. Clinical Nutrition, December 1, 2004; 80(6): 1735S - 1739S. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. W Hollis and C. L Wagner Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant Am. J. Clinical Nutrition, December 1, 2004; 80(6): 1752S - 1758S. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. T. Cantorna and B. D. Mahon Mounting Evidence for Vitamin D as an Environmental Factor Affecting Autoimmune Disease Prevalence Experimental Biology and Medicine, December 1, 2004; 229(11): 1136 - 1142. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. F McCarty Vitamin D, parathyroid hormone, and insulin sensitivity Am. J. Clinical Nutrition, November 1, 2004; 80(5): 1451 - 1452. [Full Text] [PDF]
|
|
|
|
|
|
B. W Hollis and C. L Wagner Assessment of dietary vitamin D requirements during pregnancy and lactation Am. J. Clinical Nutrition, May 1, 2004; 79(5): 717 - 726. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Cheng, F. Tylavsky, H. Kroger, M. Karkkainen, A. Lyytikainen, A. Koistinen, A. Mahonen, M. Alen, J. Halleen, K. Vaananen, et al. Association of low 25-hydroxyvitamin D concentrations with elevated parathyroid hormone concentrations and low cortical bone density in early pubertal and prepubertal Finnish girls Am. J. Clinical Nutrition, September 1, 2003; 78(3): 485 - 492. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
I A F van der Mei, A-L Ponsonby, T Dwyer, L Blizzard, R Simmons, B V Taylor, H Butzkueven, and T Kilpatrick Past exposure to sun, skin phenotype, and risk of multiple sclerosis: case-control study BMJ, August 9, 2003; 327(7410): 316. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. M. Luckey and C. Tannenbaum Authors' Response: Recommended Testing in Patients with Low Bone Density J. Clin. Endocrinol. Metab., March 1, 2003; 88(3): 1405 - 1405. [Full Text]
|
|
|
|
|
|
R. P Heaney, K M. Davies, T. C Chen, M. F Holick, and M J. Barger-Lux Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol Am. J. Clinical Nutrition, January 1, 2003; 77(1): 204 - 210. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Vieth, Y. Ladak, and P. G. Walfish Age-Related Changes in the 25-Hydroxyvitamin D Versus Parathyroid Hormone Relationship Suggest a Different Reason Why Older Adults Require More Vitamin D J. Clin. Endocrinol. Metab., January 1, 2003; 88(1): 185 - 191. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Vieth and D. Fraser Vitamin D insufficiency: no recommended dietary allowance exists for this nutrient Can. Med. Assoc. J., June 1, 2002; 166(12): 1541 - 1542. [Full Text] [PDF]
|
|
|
|
|
|
K. N. Jeejeebhoy Clinical nutrition: 6. Management of nutritional problems of patients with Crohn's disease Can. Med. Assoc. J., April 1, 2002; 166(7): 913 - 918. [Full Text] [PDF]
|
|
|
|
|
|
F. A. Muskiet, D. J. Dijck-Brouwer, E. van der Veer, and A. Schaafsma Do we really need >=100 {micro} g vitamin D/d, and is it safe for all of us? Am. J. Clinical Nutrition, December 1, 2001; 74(6): 862 - 863. [Full Text]
|
|
|
|
|
|
R. Vieth Reply to FAJ Muskiet et al Am. J. Clinical Nutrition, December 1, 2001; 74(6): 863 - 864. [Full Text]
|
|
|
|
|
|
J. Hathcock Tolerable upper intake level of vitamin D Am. J. Clinical Nutrition, December 1, 2001; 74(6): 864 - 865. [Full Text]
|
|
|
|
|
|
I. Munro Derivation of tolerable upper intake levels of nutrients Am. J. Clinical Nutrition, December 1, 2001; 74(6): 865 - 866. [Full Text]
|
|
|
|
|
|
R. Vieth Reply to J Hathcock and I Munro Am. J. Clinical Nutrition, December 1, 2001; 74(6): 866 - 867. [Full Text]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
