Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children

American Journal of Tropical Medicine and Hygiene

Volumn 91, Issue 4, 2014, Pages 777-785

  Mitchell, Nicole J ^a   Kumi, Justice ^b   Aleser, Mildred ^c   Elmore, Sarah E ^d   Rychlik, Kristal A ^d   Zychowski, Katherine E ^d   Romoser, Amelia A ^d   Phillips, Timothy D ^d   Ankrah, Nii Ayi ^b  

^a Michigan State University   (United States)

^b University of Ghana   (Ghana)

^c Ejura Sekyedumase District Hospital   (Ghana)

^d TEXAS A AND M UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFLATOXIN; MONTMORILLONITE; PLACEBO; UNCLASSIFIED DRUG; UNIFORM PARTICLE SIZE NOVASIL; ALUMINUM SILICATE; BENTONITE; CALCIUM; CLAY; MINERAL;

ABDOMINAL DISCOMFORT; AFLATOXICOSIS; ARTICLE; BLOATING; CHILD; CHILD SAFETY; CONSTIPATION; CONTROLLED STUDY; DETOXIFICATION; DIARRHEA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG URINE LEVEL; FEMALE; FLATULENCE; GHANA; HEARTBURN; HUMAN; INDIGESTION; INSOMNIA; LOSS OF APPETITE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; NAUSEA; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VOMITING; BLOOD; ENVIRONMENTAL EXPOSURE; FOOD CONTAMINATION; FOOD SAFETY; PRESCHOOL CHILD; PREVENTION AND CONTROL; URINE;

AFLATOXINS; ALUMINUM SILICATES; BENTONITE; CALCIUM; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; ENVIRONMENTAL EXPOSURE; FEMALE; FOOD CONTAMINATION; FOOD SAFETY; GHANA; HUMANS; MALE; MINERALS; TREATMENT OUTCOME;

EID: 84907703530     PISSN: 00029637     EISSN: 14761645     Source Type: Journal    
DOI: 10.4269/ajtmh.14-0093     Document Type: Article

References (71)

1. Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J, 2008. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet 371: 243-260.
2. de Onis M, Blossner M, Borghi E, 2012. Prevalence and trends of stunting among pre-school children, 1990-2020. Public Health Nutr 15: 142-148.
3. Gong YY, Hounsa A, Egal S, Turner PC, Sutcliffe AE, Hall AJ, Cardwell K, Wild CP, 2004. Postweaning exposure to aflatoxin results in impaired child growth: a longitudinal study in Benin, West Africa. Environ Health Perspect 112: 1334-1338.
4. Gong YY, Cardwell K, Hounsa A, Egal S, Turner PC, Hall AJ, Wild CP, 2002. Dietary aflatoxin exposure and impaired growth in young children from Benin and Togo: cross sectional study. BMJ 325: 20-21.
5. Gong YY, Egal S, Hounsa A, Turner PC, Hall AJ, Cardwell KF, Wild CP, 2003. Determinants of aflatoxin exposure in young children from Benin and Togo, West Africa: the critical role of weaning. Int J Epidemiol 32: 556-562.
6. Turner PC, Collinson AC, Cheung YB, Gong Y, Hall AJ, Prentice AM, Wild CP, 2007. Aflatoxin exposure in utero causes growth faltering in Gambian infants. Int J Epidemiol 36: 1119-1125.
7. Turner PC, Moore SE, Hall AJ, Prentice AM, Wild CP, 2003. Modification of immune function through exposure to dietary aflatoxin in Gambian children. Environ Health Perspect 111: 217-220.
8. Shuaib FM, Jolly PE, Ehiri JE, Yatich N, Jiang Y, Funkhouser E, Person SD, Wilson C, Ellis WO, Wang JS, Williams JH, 2010. Association between birth outcomes and aflatoxin B1 biomarker blood levels in pregnant women in Kumasi, Ghana. Trop Med Int Health 15: 160-167.
9. Abdulrazzaq YM, Osman N, Yousif ZM, Trad O, 2004. Morbidity in neonates of mothers who have ingested aflatoxins. Ann Trop Paediatr 24: 145-151.
10. Okoth SA, Ohingo M, 2004. Dietary aflatoxin exposure and impaired growth in young children from Kisumu District, Kenya: cross sectional study. Afr J Health Sci 11: 43-54.
11. Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M, 2008. What works? Interventions for maternal and child undernutrition and survival. Lancet 371: 417-440.
12. Hendricks KM, 2010. Ready-to-use therapeutic food for prevention of childhood undernutrition. Nutr Rev 68: 429-435.
13. Lartey A, Manu A, Brown KH, Peerson JM, Dewey KG, 1999. A randomized, community-based trial of the effects of improved, centrally processed complementary foods on growth and micronutrient status of Ghanaian infants from 6 to 12 mo of age. Am J Clin Nutr 70: 391-404.
14. Kumi J, Nicole M, Asare GA, Dotse E, Kwaa F, Phillips T, Ankrah N-A, 2013. Aflatoxins and fumonisins contamination of home-made food (weanimix) from cereal-legume blends for children in Ghana. Toxicol Lett 221: S119
15. Polychronaki N, Wild C, Mykkänen H, Amra H, Abdel-Wahhab M, Sylla A, Diallo M, El-Nezami H, Turner P, 2008. Urinary biomarkers of aflatoxin exposure in young children from Egypt and Guinea. Food Chem Toxicol 46: 519-526.
16. Turner PC, Mendy M, Whittle H, Fortuin M, Hall AJ, Wild CP, 2000. Hepatitis B infection and aflatoxin biomarker levels in Gambian children. Trop Med Int Health 5: 837-841.
17. Turner PC, Sylla A, Kuang SY, Marchant CL, Diallo MS, Hall AJ, Groopman JD, Wild CP, 2005. Absence of TP53 codon 249 mutations in young Guinean children with high aflatoxin exposure. Cancer Epidemiol Biomarkers Prev 14: 2053-2055.
18. Wild C, Fortuin M, Donato F, Whittle H, Hall A, Wolf C, Montesano R, 1993. Aflatoxin, liver enzymes, and hepatitis B virus infection in Gambian children. Cancer Epidemiol Biomarkers Prev 2: 555-561.
19. Wild C, Jiang Y, Allen S, Jansen L, Hall A, Montesano R, 1990. Aflatoxin-albumin adducts in human sera from different regions of the world. Carcinogenesis 11: 2271-2274.
20. Obuseh FA, Jolly PE, Jiang Y, Shuaib FM, Waterbor J, Ellis WO, Piyathilake CJ, Desmond RA, Afriyie-Gyawu E, Phillips TD, 2010. Aflatoxin B1 albumin adducts in plasma and aflatoxin M1 in urine are associated with plasma concentrations of vitamins A and E. Int J Vitam Nutr Res 80: 355-368.
21. Gong YY, Wilson S, Mwatha JK, Routledge MN, Castelino JM, Zhao B, Kimani G, Kariuki HC, Vennervald BJ, Dunne DW, Wild CP, 2012. Aflatoxin exposure may contribute to chronic hepatomegaly in Kenyan school children. Environ Health Perspect 120: 893-896.
22. Jiang Y, Jolly PE, Ellis WO, Wang JS, Phillips TD, Williams JH, 2005. Aflatoxin B1 albumin adduct levels and cellular immune status in Ghanaians. Int Immunol 17: 807-814.
23. IARC, 1993. Some Naturally Occurring Substances: Food Items and Constituents, Heterocyclic Aromatic Amines and Mycotoxins. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Lyon, France: International Agency for Research on Cancer.
24. IARC, 2002. Aflatoxins. IARC Monograph on the Evaluation of Carcinogenic Risks to Humans. Lyon, France: International Agency for Research on Cancer, 171.
25. Kocabas CN, Coskun T, Yurdakok M, Haziroglu R, 2003. The effects of aflatoxin B1 on the development of kwashiorkor in mice. Hum Exp Toxicol 22: 155-158.
26. Cheng YH, Shen TF, Pang VF, Chen BJ, 2001. Effects of aflatoxin and carotenoids on growth performance and immune response in mule ducklings. Comp Biochem Physiol C Toxicol Pharmacol 128: 19-26.
27. Giambrone JJ, Diener UL, Davis ND, Panangala VS, Hoerr FJ, 1985. Effects of aflatoxin on young turkeys and broiler chickens. Poult Sci 64: 1678-1684.
28. Giambrone JJ, Diener UL, Davis ND, Panangala VS, Hoerr FJ, 1985. Effect of purified aflatoxin on turkeys. Poult Sci 64: 859-865.
29. Harvey RB, Edrington TS, Kubena LF, Elissalde MH, Rottinghaus GE, 1995. Influence of aflatoxin and fumonisin B1-containing culture material on growing barrows. Am J Vet Res 56: 1668-1672.
30. Harvey RB, Huff WE, Kubena LF, Phillips TD, 1989. Evaluation of diets contaminated with aflatoxin and ochratoxin fed to growing pigs. Am J Vet Res 50: 1400-1405.
31. Harvey RB, Kubena LF, Huff WE, Corrier DE, Clark DE, Phillips TD, 1989. Effects of aflatoxin, deoxynivalenol, and their combinations in the diets of growing pigs. Am J Vet Res 50: 602-607.
32. Harvey RB, Kubena LF, Huff WE, Corrier DE, Rottinghaus GE, Phillips TD, 1990. Effects of treatment of growing swine with aflatoxin and T-2 toxin. Am J Vet Res 51: 1688-1693.
33. Khlangwiset P, Shephard GS, Wu F, 2011. Aflatoxins and growth impairment: a review. Crit Rev Toxicol 41: 740-755.
34. Pimpukdee K, Kubena LF, Bailey CA, Huebner HJ, Afriyie-Gyawu E, Phillips TD, 2004. Aflatoxin-induced toxicity and depletion of hepatic vitamin A in young broiler chicks: protection of chicks in the presence of low levels of NovaSil PLUS in the diet. Poult Sci 83: 737-744.
35. Wogan G, 1969. Metabolism and biochemical effects of aflatoxins. Goldblatt L, ed. Aflatoxin: Scientific Background, Control, and Implications. New York, NY: Academic Press, Inc.
36. Phillips TD, Kubena LF, Harvey RB, Taylor DR, Heidelbaugh ND, 1988. Hydrated sodium calcium aluminosilicate: a high affinity sorbent for aflatoxin. Poult Sci 67: 243-247.
37. Phillips TD, Afriyie-Gyawu E, Williams J, Huebner H, Ankrah NA, Ofori-Adjei D, Jolly P, Johnson N, Taylor J, Marroquin-Cardona A, Xu L, Tang L, Wang JS, 2008. Reducing human exposure to aflatoxin through the use of clay: a review. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25: 134-145.
38. Sarr AB, Mayura K, Kubena LF, Harvey RB, Phillips TD, 1995. Effects of phyllosilicate clay on the metabolic profile of aflatoxin B1 in Fischer-344 rats. Toxicol Lett 75: 145-151.
39. Harvey RB, Kubena LF, Elissalde MH, Corrier DE, Phillips TD, 1994. Comparison of two hydrated sodium calcium alumino-silicate compounds to experimentally protect growing barrows from aflatoxicosis. J Vet Diagn Invest 6: 88-92.
40. Harvey RB, Kubena LF, Phillips TD, Huff WE, Corrier DE, 1989. Prevention of aflatoxicosis by addition of hydrated sodium calcium aluminosilicate to the diets of growing barrows. Am J Vet Res 50: 416-420.
41. Bingham AK, Huebner HJ, Phillips TD, Bauer JE, 2004. Identification and reduction of urinary aflatoxin metabolites in dogs. Food Chem Toxicol 42: 1851-1858.
42. Harvey RB, Phillips TD, Ellis JA, Kubena LF, Huff WE, Petersen HD, 1991. Effects on aflatoxin M1 residues in milk by addition of hydrated sodium calcium aluminosilicate to aflatoxin-contaminated diets of dairy cows. Am J Vet Res 52: 1556-1559.
43. Phillips TD, 1999. Dietary clay in the chemoprevention of aflatoxin-induced disease. Toxicol Sci 52: 118-126.
44. Wang P, Afriyie-Gyawu E, Tang Y, Johnson NM, Xu L, Tang L, Huebner HJ, Ankrah NA, Ofori-Adjei D, Ellis W, Jolly PE, Williams JH, Wang JS, Phillips TD, 2008. NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis: II. Reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25: 622-634.
45. Mitchell NJ, Kumi J, Johnson NM, Dotse E, Marroquin-Cardona A, Wang JS, Jolly PE, Ankrah NA, Phillips TD, 2013. Reduction in the urinary aflatoxin M1 biomarker as an early indicator of the efficacy of dietary interventions to reduce exposure to aflatoxins. Biomarkers 18: 391-398.
46. Marroquin-Cardona A, Deng Y, Garcia-Mazcorro J, Johnson NM, Mitchell N, Tang L, Robinson A 2nd, Taylor J, Wang JS, Phillips TD, 2011. Characterization and safety of uniform particle size Novasil clay as a potential aflatoxin enterosorbent. Appl Clay Sci 54: 248-257.
47. Afriyie-Gyawu E, Mackie J, Dash B, Wiles M, Taylor J, Huebner H, Tang L, Guan H, Wang JS, Phillips T, 2005. Chronic toxicological evaluation of dietary NovaSil clay in Sprague-Dawley rats. Food Addit Contam 22: 259-269.
48. Wiles M, Huebner H, Afriyie-Gyawu E, Taylor R, Bratton G, Phillips T, 2004. Toxicological evaluation and metal bioavailability in pregnant rats following exposure to clay minerals in the diet. J Toxicol Environ Health A 67: 863-874.
49. Afriyie-Gyawu E, Ankrah NA, Huebner HJ, Ofosuhene M, Kumi J, Johnson NM, Tang L, Xu L, Jolly PE, Ellis WO, Ofori-Adjei D, Williams JH, Wang JS, Phillips TD, 2008. NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25: 76-87.
50. Afriyie-Gyawu E, Wang Z, Ankrah NA, Xu L, Johnson NM, Tang L, Guan H, Huebner HJ, Jolly PE, Ellis WO, Taylor R, Brattin B, Ofori-Adjei D, Williams JH, Wang JS, Phillips TD, 2008. NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25: 872-884.
51. Wang JS, Luo H, Billam M, Wang Z, Guan H, Tang L, Goldston T, Afriyie-Gwayu E, Lovett C, Griswold J, Brattin B, Taylor RJ, Huebner HJ, Phillips TD, 2005. Short-term safety evaluation of processed calcium montmorillonite clay (NovaSil) in humans. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 22: 270-279.
52. Zeh CE, Odhiambo CO, Mills LA, 2012. Laboratory Reference Intervals in Africa, Blood Cell - An Overview of Studies in Hematology. T. Moschandreou, (Ed.), ISBN: 978-953-51-0753-8, InTech, DOI:10.5772/48250. Available at: http://www .intechopen.com/books/blood-cell-an-overview-of-studies-inhematology/laboratory-reference-intervals-in-africa.
53. Groopman JD, Zhu JQ, Donahue PR, Pikul A, Zhang LS, Chen JS, Wogan GN, 1992. Molecular dosimetry of urinary aflatoxin-DNA adducts in people living in Guangxi Autonomous Region, People's Republic of China. Cancer Res 52: 45-52.
54. World Health Organization, 2012. World Malaria Report. Available at: http://www.who.int/malaria/publications/world-malaria-report-2012/report/en/. Accessed January 10, 2013.
55. Jolly PE, Jiang Y, Ellis W, Awuah R, Nnedu O, Phillips T, Wang JS, Afriyie-Gyawu E, Tang L, Person S, Williams J, Jolly C, 2006. Determinants of aflatoxin levels in Ghanaians: sociodemographic factors, knowledge of aflatoxin and food handling and consumption practices. Int J Hyg Environ Health 209: 345-358.
56. Jolly PE, Shuaib FM, Jiang Y, Preko P, Baidoo J, Stiles JK, Wang JS, Phillips TD, Williams JH, 2011. Association of high viral load and abnormal liver function with high aflatoxin B1-albumin adduct levels in HIV-positive Ghanaians: preliminary observations. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 28: 1224-1234.
57. Inungu JN, 1995. Prevalence of malnutrition among school children in Ejisu-Juaben District, Ashanti region in Ghana. Afr J Health Sci 2: 385-387.
58. Kumi J, Mitchell N, Asare GA, Dotse E, Kwaa F, Phillips TD, Ankrah NA, 2011. Occurrence of Aflatoxin in Homemade Nutritional Supplement for Infants in Ghana. Proceedings of the Gordon Research Conference: Mycotoxins & Phycotoxins; June 12-17, Easton, MA.
59. Shephard GS, 2003. Aflatoxin and food safety: recent African perspectives. Toxin Rev 22: 267-286.
60. Dupont C, Foo JL, Garnier P, Moore N, Mathiex-Fortunet H, Salazar-Lindo E, 2009. Oral diosmectite reduces stool output and diarrhea duration in children with acute watery diarrhea. Clin Gastroenterol Hepatol 7: 456-462.
61. Lexomboon U, Harikul S, Lortholary O, 1994. Control randomized study of rehydration/rehydration with dioctahedral smectite in ambulatory Thai infants with acute diarrhea. Southeast Asian J Trop Med Public Health 25: 157-162.
62. Madkour AA, Madina EM, el-Azzouni OE, Amer MA, el-Walili TM, Abbass T, 1993. Smectite in acute diarrhea in children: a double-blind placebo-controlled clinical trial. J Pediatr Gastroenterol Nutr 17: 176-181.
63. Szajewska H, Dziechciarz P, Mrukowicz J, 2006. Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children. Aliment Pharmacol Ther 23: 217-227.
64. George-Gay B, Parker K, 2003. Understanding the complete blood count with differential. J Perianesth Nurs 18: 96-114.
65. Smith E, Phillips T, Ellis J, Harvey R, Kubena L, Thompson J, Newton G, 1994. Dietary hydrated sodium calcium aluminosilicate reduction of aflatoxin M1 residue in dairy goat milk and effects on milk production and components. J Anim Sci 72: 677.
66. Schell TC, Lindemann MD, Kornegay ET, Blodgett DJ, 1993. Effects of feeding aflatoxin-contaminated diets with and without clay to weanling and growing pigs on performance, liver function, and mineral metabolism. J Anim Sci 71: 1209-1218.
67. Reinhart RA, 1988. Magnesium metabolism. A review with special reference to the relationship between intracellular content and serum levels. Arch Intern Med 148: 2415-2420.
68. Clark J, Hatch R, Miller D, Jain A, 1984. Caprine aflatoxicosis: experimental disease and clinical pathologic changes. Am J Vet Res 45: 1132-1135.
69. Cliffford JI, Rees KR, 1967. The action of aflatoxin B1 on the rat liver. Biochem J 102: 65-75.
70. Sokol R, Stall C, 1990. Anthropometric evaluation of children with chronic liver disease. Am J Clin Nutr 52: 203-208.
71. Wild CP, Yin F, Turner PC, Chemin I, Chapot B, Mendy M, Whittle H, Kirk GD, Hall AJ, 2000. Environmental and genetic determinants of aflatoxin-albumin adducts in the Gambia. Int J Cancer 86: 1-7.