A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market

Nutrition in Clinical Practice

Volumn 30, Issue 4, 2015, Pages 559-569

  Vanek, Vincent W ^a   Borum, Peggy ^b   Buchman, Alan ^c   Fessler, Theresa A ^d   Howard, Lyn ^e   Shenkin, Alan ^f   Valentine, Christina J ^g  

^a Department of Internal Medicine Mercy Health System   (United States)

^b UNIVERSITY OF FLORIDA   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d UNIVERSITY OF VIRGINIA   (United States)

^e ALBANY MEDICAL COLLEGE   (United States)

^f ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^g Mead Johnson Pediatric Nutrition Institute   (United States)

Author keywords

micronutrients; minerals; parenteral nutrition; parenteral nutrition solutions; trace elements; vitamins

Indexed keywords

CARNITINE; CHOLINE; TRACE ELEMENT; LIPOTROPIC AGENT; VITAMIN; VITAMIN D;

ARTICLE; CONSENSUS; FOOD AND DRUG ADMINISTRATION; GROUPS BY AGE; HUMAN; MARKET; PARENTERAL NUTRITION; UNITED STATES; VITAMIN SUPPLEMENTATION; ADULT; DIETARY SUPPLEMENT; DRUG APPROVAL; INFANT; STANDARDS; TOXICITY;

ADULT; CARNITINE; CHOLINE; DIETARY SUPPLEMENTS; DRUG APPROVAL; HUMANS; INFANT; LIPOTROPIC AGENTS; MICRONUTRIENTS; PARENTERAL NUTRITION; TRACE ELEMENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VITAMIN D; VITAMINS;

EID: 84937844735     PISSN: 08845336     EISSN: 19412452     Source Type: Journal    
DOI: 10.1177/0884533615589992     Document Type: Article

References (51)

1. Okada A, Takagi Y, IIeakura T,. Skin lesions during intravenous hyperalimentation: zinc deficiency. Surgery. 1976; 80: 629-635.
2. Kay RG, Tasman-Jones C, Pybus J,. A syndrome of acute zinc deficiency during total parenteral alimentation in man. Ann Surg. 1976; 183 (4): 331-340.
3. Heller RM, Kirchner SA, ONeill JA Jr,. Skeletal changes of copper deficiency in infants receiving prolonged total parenteral nutrition. J Pediatr. 1978; 92 (6): 947-949.
4. Karpel JT, Peden VH,. Copper deficiency in long-term parenteral nutrition. J Pediatr. 1972; 80: 32-36.
5. Vilter RW, Bozian RC, Hess EV,. Manifestations of copper deficiency in patient with systemic sclerosis on intravenous hyperalimentation. N Engl J Med. 1974; 29: 188-193.
6. Jeejeebhoy KN, Chu RC, Marliss EB,. Chromium deficiency, glucose intolerance and neuropathy reversed by chromium supplementation in a patient receiving long term total parenteral nutrition. Am J Clin Nutr. 1977; 30: 535-538.
7. Freund H, Atamian J, Fisher JE,. Chromium deficiency during total parenteral nutrition. JAMA. 1979; 241: 496-498.
8. van Rij AM, Thompson CD, McKenzie JM,. Selenium deficiency in total parenteral nutrition. Am J Clin Nutr. 1979; 32: 2076-2085.
9. American Medical Association Symposium on Total Parenteral Nutrition. January 17-19, 1972; Nashville, TN.
10. Shils ME, Baker H, Frank O,. Blood vitamin levels of long-term adult home total parenteral nutrition patients: the efficacy of the AMA-FDA parenteral multivitamin formulation. JPEN J Parenter Enteral Nutr. 1985; 9 (2): 179-188.
11. Council for Responsible Nutrition. Comparison of Daily Values (DVs): Vitamins. http://www.crnusa.org/pdfs/CRN-ComparisonTablesDVs.pdf. Accessed May 8, 2015.
12. Howard L, Bigaouette J, Chu R,. Water soluble vitamin requirements in home parenteral nutrition patients. Am J Clin Nutr. 1983; 37 (3): 421-428.
13. Labadarios D, OKeefe S, Dicker J,. Plasma vitamin levels in patients on prolonged total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1988; 12 (2): 205-211.
14. Dempsey DT, Mullen JL, Rombeau JL,. Treatment effects of parenteral vitamins in total parenteral nutrition patients. JPEN J Parenter Enteral Nutr. 1987; 11 (3): 229-237.
15. Inculet RI, Norton JA, Nichoalds GE,. Water-soluble vitamins in cancer patients on parenteral nutrition: a prospective study. JPEN J Parenter Enteral Nutr. 1987; 11 (3): 243-249.
16. Stromberg P, Shenkin A, Campbell RA,. Vitamin status during total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1981; 5 (4): 295-299.
17. Federal Register. Parenteral multivitamin products; drugs for human use; drug efficacy study implementation; amendment. https://federalregister.gov/a/00-9848. Published 20, 2000. Accessed May 12, 2015.
18. Guidelines for essential trace element preparations for parenteral use: a statement by an expert panel. JAMA. 1979; 24: 2051-2054.
19. Keshan Disease Research Group. Observations on effect of sodium selenite in prevention of Keshan disease. Chin Med J. 1979; 92 (7): 471-476.
20. Fell JM, Reynolds AP, Meadows N,. Manganese toxicity in children receiving long-term parenteral nutrition. Lancet. 1996; 347: 1218-1221.
21. Buchman AL,. Manganese. In: Ross AC, Caballero B, Cousins RJ, Tucker KL, Ziegler TR, eds. Modern Nutrition in Health and Disease. 11th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2014: 238-244.
22. Reynolds N, Blumsohn A, Baxter JP, Houston G, Pennington CR,. Manganese requirement and toxicity in patients on home parenteral nutrition. Clin Nutr. 1998; 17 (5): 227-230.
23. Huang C, Chu N, Lu C,. Chronic manganese intoxication. Arch Neurol. 1989; 46: 1104-1106.
24. Howard L, Ashley C, Lyon D,. Autopsy tissue trace elements in 8 long-term parenteral nutrition patients who received the current U.S. Food and Drug Administration Formulation. JPEN J Parenter Enteral Nutr. 2007; 31 (5): 388-396.
25. Takagi Y, Okada A, Sando K,. Evaluation of indexes of in vivo manganese status and the optimal intravenous dose for adult patients undergoing home parenteral nutrition. Am J Clin Nutr. 2002; 75: 112-118.
26. Fitzgerald K, Mikalunas V, Rubin H,. Hypermanganesemia in patients receiving total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1999; 23 (6): 333-336.
27. Wardle CA, Forbes A, Roberts NB, Jawhari AV, Shenkin A,. Hypemanganesemia in long term intravenous nutrition and chronic liver disease. JPEN J Parenter Enteral Nutr. 1999; 23 (6): 350-355.
28. Takagi Y, Okada A, Sando K, Wasa M, Yoshida H, Hirabuki N,. On-off study of manganese administration to adult patients undergoing home parenteral nutrition: new indices of in vivo manganese level. JPEN J Parenter Enteral Nutr. 2001; 25 (2): 87-92.
29. Dickerson RN,. Manganese intoxication and parenteral nutrition. Nutrition. 2001; 17 (7-8): 689-693.
30. Hardy IJ, Gillanders L, Hardy G,. Is manganese an essential supplement for parenteral nutrition? Curr Opin Clin Nutr Metab Care. 2008; 11 (3): 289-296.
31. Shike M, Roulet M, Kurian R,. Copper metabolism and requirement in total parenteral nutrition. Gastroenterology. 1981; 81 (2): 290-297.
32. Blaszyk H, Wild PJ, Oliveira A,. Hepatic copper in patients receiving long-term total parenteral nutrition. J Clin Gastroenterol. 2005; 39 (4): 318-320.
33. Moukarzel AA, Song MK, Buchman AL,. Excessive chromium intake in children receiving total parenteral nutrition. Lancet. 1992; 339: 385-388.
34. Moukarzel AA,. Chromium in parenteral nutrition: too little or too much? Gastroenterology. 2009; 137 (5 suppl): S18-S28.
35. Pluhator-Murton MM, Fedorak RN, Audette RJ,. Trace element contamination of total parenteral nutrition, 1. Contribution of component solutions. JPEN J Parenter Enteral Nutr. 1999; 23 (4): 222-227.
36. Verhage AH, Cheong WK, Jeejeebhoy KN,. Neurologic symptoms due to possible chromium deficiency in long-term parenteral nutrition that closely mimic metronidazole-induced syndromes. JPEN J Parenter Enteral Nutr. 1996; 20 (2): 123-127.
37. Ito Y, Alcock NW, Shils ME,. Chromium content of total parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 1990; 14 (6): 610-614.
38. Leung FY, Galbraith LV,. Elevated serum chromium in patients on total parenteral nutrition and the ionic species of contaminant chromium. Biol Trac Elem Res. 1995; 50 (3): 221-228.
39. Mouser JF, Hak EB, Helms RA, Christensen ML, Storm MC,. Chromium and zinc concentrations in pediatric patients receiving long-term parenteral nutrition. Am J Health Syst Pharm. 1999; 56 (19): 1950-1956.
40. Bougle D, Bureau F., Deschrevel G, Hecquard C, Neuville D, Drosdowsky M, Duhamel JF,. Chromium and parenteral nutrition in children. J Pediat Gastroenterol Nutr. 1993; 17 (1): 72-74.
41. Vanek VW, Borum P, Buchman A,. A.S.P.E.N. position paper: recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012; 27 (4): 440-491.
42. Nilsen FH,. Micronutrients in parenteral nutrition: boron, silicon, and fluoride. Gastroenterology. 2009; 137 (5 suppl): S55-S60.
43. Borum PR,. Carnitine in parenteral nutrition. Gastroenterology. 2009; 137 (5 suppl): S129-S134.
44. Buchman AL,. The addition of choline to parenteral nutrition. Gastroenterology. 2009; 137 (5 suppl): S119-S128.
45. Corey B, Ackerman K, Allen P, Sceery N, Rafoth C,. Vitamin D status of New England home TPN patients-a snapshot of practice [abstract]. Nutr Clin Pract. 2009; 24 (1): 110.
46. Boullata J, Compher C, Schiavone P,. Oral vitamin D repletion in patients with parenteral nutrition-dependent intestinal failure [abstract]. Nutr Clin Pract. 2009; 24 (1): 138-139.
47. Thomson P, Duerksen DR,. Vitamin D deficiency in patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2011; 35 (4): 499-504.
48. Kumar PR, Fenton TR, Shaheen AA, Raman M,. Prevalence of vitamin D deficiency and response to oral vitamin D supplementation in patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2012; 36 (4): 463-469.
49. Greene HL, Hambidge M, Schanler R, Tsang RC,. Guidelines for the use of vitamins, trace elements, calcium, magnesium, and phosphorus in infant and children receiving total parenteral nutrition: report of the Subcommittee on Pediatric Parenteral Nutrient Requirements from the Committee on Clinical Practice Issues of The American Society for Clinical Nutrition. Am J Clin Nutr. 1988; 48 (5): 1324-1342.
50. Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R, Parenteral Nutrition Guidelines Working Group; European Society for Clinical Nutrition and Metabolism; European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN); European Society of Paediatric Research (ESPR). 1. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr. 2005; 41 (suppl 2): S1-S87.
51. Domellof M,. Nutritional care of premature infants: microminerals. In: Koletzko B, Poindexter B, Uauy R, eds. Nutritional Care of Preterm Infants-Scientific Basis and Practical Guidelines. Basal, Switzerland: S. Karger AG; 2014: 121-139.