Arzneimittelforschung 2008; 58(8): 389-397
DOI: 10.1055/s-0031-1296526
Therapeutics for States of Deficiency
Editio Cantor Verlag Aulendorf (Germany)

Effects of Oral Supplementation with Iron (III) Hydroxide Polymaltose Complex on the Hematological Profile of Adolescents with Varying Iron Status

A single centre prospective placebo controlled study
Pallaki Baby Devaki
1   Department of Home Science, S.V. University, Tirupati, AP, India
,
Ranjit K. Chandra
2   Allergy, Asthma and Immunology Center, Gurgaon, Haryana, India
,
Peter Geisser
3   Vifor (International) Inc. Pharmaceutical Products, St. Gallen, Switzerland
› Author Affiliations
Further Information

Publication History

Publication Date:
15 December 2011 (online)

Abstract

Objective:

To assess the effects of supplementation with oral iron(III) hydroxide polymaltose complex on the iron status of adolescents with and without iron deficiency and anemia.

Method:

Adolescents of both sexes with varying iron status were allocated to four treatment groups by using inclusion criteria. Three of the four groups received iron(III) hydroxide polymaltose complex (IPC, Maltofer®) containing100 mg of iron 6 days a week for 8 months. The fourth group was given a placebo. Hematological parameters were assessed at the baseline and after 4 and 8 months of supplementation.

Results:

IPC supplementation resulted in a significant increase in iron parameters in all the three supplemented groups including correction of iron deficiency and anemia along with improvement in storage iron after 8 months. No side effects were noted in any of the supplemented subjects.

Conclusions:

IPC supplementation im proved the iron status of adolescents with and without iron deficiency and anemia. These data provide evidence that IPC is an easy-to-administer and well tolerated compound which can improve and normalize the iron status of iron deficient and anemic patients.

 
  • Literature

  • 1 Nair MKC. Overview of adolescent problems. J Indian Med Ass. 2003; 101 (11) 651-653 663
  • 2 Sanghvi TG. Economic Rationale for Investing in Micronutrient Programs. A Policy Brief Based on New Analyses, Office of Nutrition, Bureau for Research and Development Washington (DC): United States Agency for International Development; 1996. p. 1-12
  • 3 Micro nutrient deficiency disorders in 16 districts of India. Part I. Report of an ICMR Task Force Study - District Nutrition Project. New Delhi: Indian Council of Medical Research (ICMR); 2001.
  • 4 Ministry of Health and Family Welfare (MOHFW) Key findings National Family Health Survey-2, Mumbai, MOFHW,. Govt. of India/International Institute of Population Studies (1998–1999)
  • 5 Krishna Swamy K, Sarma R. Health and nutritional status of women and adolescent girls in India in empowerment of women with special reference to women’s health. Workshop by National Commission for Women Tirupati (India): S.V. University; 2000. p 47-58
  • 6 Voluntary Health Association of India (VHAI), www.pdr.health.com; 2005.
  • 7 Survival for Women And Children (SWACH) Foundation, Anemia in pregnant women and adolescent girls in rural areas of \Haryana, India. Quarterly Progress Repost: April to June 1997. Submitted mother care project, Johnsnow, Inc. 1997.
  • 8 Kurz KM, Johnson-Welch C. The nutrition and lives of adolescents in developing countries: Findings from the nutrition of adolescent girls research program. Washington (DC): International centre for research on women; 1994. p. 34
  • 9 Mehta S. Effectiveness of daily and weekly iron and folic acid supplementation in anaemic adolescent girls (1996–1998). UNICEF funded Final Report of the Research Project, Bombay Urban ICDS Project 1998 pp. 21-25
  • 10 Seshadri S. Oral iron supplementation to control anemia in adolescent girls. Community trails of effectiveness of daily vs weekly supplementation. UNICEF Project of Department of Foods and Nutrition/WHO Collaborating Centre for Anemia Control Baroda (India): Maharaja Sayajirao University; 1998. p. 26
  • 11 Agarwal KN Assessment of prevalence of anemia and iron in response to daily/weekly iron folate supplementation in adolescent girls (w-18y) from urban slums in North East Delhi: UNICEF Contract no. 95/0075 1998 pp 1-9
  • 12 Levin HMA. Benefit-cost analysis of nutritional programs of anemia reduction. Res. Observ. 1986; 1: 219-245
  • 13 Dallman PR. Manifestations of iron deficiency. Semin He-matol. 1982; 19: 19-30
  • 14 Tuomainen TP, Nyyssonen K, Porkkala-Sarataho E, Salonen R, Baumgartner JA, Geisser P et al. Oral supplementation with ferrous sulfate but not with non-ionic iron polymaltose complex increases the susceptibility of plasma lipoproteins to oxidation. Nutr Res. 1999; 19: 1121-1132
  • 15 Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parental iron preparations. Arzneimittel-Forschung (Drug Research). 1992; 42: 1439-1452
  • 16 Grandjean EM. Scientific report on the clinical safety of the Iron(III) Hydroxide Polymaltose Complex (Maltofer®). St. Gallen (Switzerland): Vifor (International) Inc.; 1997
  • 17 Cook JD, Finch CA. Assessing iron status of a population. Am J Clin Nutr. 1979; 32: 2115-2119
  • 18 Prevalence of nutritional anemia in women in developing countries. Geneva: WHO; 1979
  • 19 Mamatha B. Effect of iron deficiency and supplementation on taste thresholds of adolescent girls. [dissertation] (MSc) Tirupati (A.P.,India); S.V. University: 1986
  • 20 Ramamohan V. Effect of iron deficiency on taste perception and preferences of university women students [dissertation] (MSc). Tirupati (A.P., India): S.V. University; 1984
  • 21 Devaki PB. Iron deficiency related functional consequences in young adults. Doctoral thesis Tirupati (A.P., India): S.V. University; 1993
  • 22 Bothwell TH, Charlton RW, Cook JD. Iron Metabolism in Man. Oxford: Blackwell Scientific Publications; 1979
  • 23 Jagadeesan V, Kaladhar M. Trace elements of nutritional importance. In: Bamji M, Pralhad Rao N, Reddy V. (editors) Text Book of Human Nutrition. New Delhi: Oxford and IBH Publishing Co.; 1999. pp. 108-121
  • 24 Seshadri S, Gopaldas T. Impact of iron supplementation on cognitive function in preschool and school-aged children: The Indian experience. Am J Clin Nutr. 1989; 50: 675-684
  • 25 Pollitt EP, Hathirat NJ, Kotchabhakdi L, Missell L, Valyasevi A. Iron deficiency and educational achievement in Thailand. Am J Clin Nutr. 1989; 50: 687-94
  • 26 International Anemia Consultative Group (INACG) Measurements of iron status, A report of the International Nutritional Anemia Consultative Group. Washington (DC): The Nutrition Foundation; 1985: 35-54
  • 27 Jacobs P, Dommisse J. The plasma ferritin level as a reliable index of body iron stores following intravenous iron dex-tran. J Med. 1982; 13: 309-321
  • 28 Callender ST. Treatment of iron deficiency. Clin Hematol. 1982; 11: 327-
  • 29 Crichton RR, Danielson BG, Geisser P. Iron therapy with special emphasis on oxidative stress. 3rd ed Bremen (Germany): UNI-MED; 2006
  • 30 Girdwood RH. Treatment of anemia. Br Med J. 1952; 1: 599-
  • 31 Langstaff RJ, Geisser P, Heil WG, Bowdler JM. Treatment of iron-deficiency anemia: a lower incidence of adverse effects with Ferrum Hausmann than ferrous sulfate. Br J Clin Res. 1993; 4: 191-198
  • 32 Jacobs P, Wormald LA, Gregorg MC. Absorption of iron polymaltose and ferrous sulfate in rats and humans. S Afr Med J. 1979; 55: 1065-1072
  • 33 Jacobs P, Johnson G, Wood L. Oral iron therapy in human subjects comparative absorption between ferrous salts and iron polymaltose. J Med. 1984; 15: 367-377
  • 34 Sas G, Nemesanszky E, Brauer H, Scheffer K. On the therapeutic effects of trivalent and divalent iron in iron deficiency anemia. Arzneimittel-Forschung (Drug Research). 1984; 24: 1575-1579
  • 35 Kaltwasser JP, Werner E, Niechzial M. Bioavailability and therapeutic efficacy of bivalent and trivalent iron preparations. Arzneimittel-Forschung (Drug Research). 1987; 37: 122-129
  • 36 Eckstein RP, Symons P. Iron tablets cause histopathologi-cally distinctive lesions in mucosal biopsies of the stomach and esophagus. Pathology. 1996; 28: 142-145
  • 37 Naito Y, Yoshikawa T, Yoneta T, Yagi N, Matsuyama K, Arai M et al. A new gastric ulcer model in rats produced by ferrous iron and ascorbic acid injection. Digestion. 1995; 56: 472-478
  • 38 Hider R, Bonkovsky HL, Ponka P, Bacon BR, Drysdale J, Grace ND et al. An update on iron metabolism: Summary of the fifth international conference on disorders of iron metabolism. Hepatology. 1996; 24: 718-729
  • 39 Huntingdon Life Sciences, Iron polymaltose complex; toxicity to dogs by repeated oral administration for 52 weeks. Vifor (International) Inc.; 1998.
  • 40 Schmidt BJ, Morais MB, Fisberg M, Martins A, Machado N. Comparação terapêutica entre o sulfato ferroso e o ferro trivalente em forma de complexo dehidróxido férrico poli-maltosado na deficiência orgânica de ferro. [Therapeutic comparison between ferrous sulphate and trivalent iron in the form of a polymaltosed ferric hydroxide complex in organic iron deficiency] Folha Med. 1985; 90: 25-29