Evaluation of safety and tolerability of iron amino acid chelate therapy in pregnant women


  • Sunita Chandra National Clinical Director for Morpheus IVF
  • Surya Narayan Mohanty Consultant, Care Hospital, Bhubaneswar, Odisha, India
  • Manju Gupta Consultant Women and Child Clinic, India
  • Vinay Purohit Medical Advisor, Lupin Limited, India
  • Reshma Parekar Medical Advisor, Lupin Limited, India




Anemia, iron deficiency anemia, Iron amino acid chelate, Hemoglobin, pregnancy


Background: Anemia is a major health problem. Iron deficiency is the most common cause of anemia during pregnancy. It can be associated with increased preterm labor, preeclampsia, and maternal sepsis. It can also lead to fetal loss or even perinatal deaths. The aim of the study was to monitor the oral iron therapy [Iron Amino Acid Chelate (IAAC) equivalent to elemental iron 30 mg] administered according to hospital practice and to determine the safety, and tolerability of IAAC in pregnant women.

Methods: The data of pregnant women attending the outpatient department of the hospital for antenatal care between March 2020 and February 2021 and prescribed IAAC was retrospectively analyzed. It was of interest to note the changes in the Hemoglobin (Hb) levels and serum ferritin levels. These parameters were considered as the primary efficacy parameter and were analyzed by the paired t-test.

Results: The data indicated very well tolerance to IAAC preparation with increase in Hb levels. After 12 week of treatment, there were significant increases in hemoglobin levels with mean rise in Hb level was 7 to 9 gm/dL. A statistically significant difference was observed at the 4th, 8th, and 12th weeks from the baseline value to each evaluation in the Hb level due to the supplementation of oral iron.  The change in the serum ferritin levels was found to be statistically significant at the 12th week from the baseline values. Most of the women tolerated the oral IAAC preparation

Conclusions: This retrospective analysis showcased a significant improvement in the Hb and serum ferritin levels of pregnant women after 12 weeks.

Author Biography

Sunita Chandra, National Clinical Director for Morpheus IVF

National Clinical Director


Anaemia. World Health Organization. Available at: https://www.who.int/health-topics/anaemia#ta b=tab_1. Accessed on 20 February 2022.

Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021;397(10270):233-48.

Yadav K, Arjun MC, Jacob OM, Kant S, Ahamed F, Ramaswamy G. Comparison of different doses of daily iron supplementation for anemia prophylaxis in pregnancy: A systematic review. J Family Med Prim Care. 2020;9(3):1308-16.

National Family Health Survey (NFHS-4), 2015–16. Available at: http://rchiips.org/nfhs/nfhs-4Reports/India.pdf. Accessed on 20 January 2022.

Tandon R, Jain A, Malhotra P. Management of iron deficiency anemia in pregnancy in India. Indian J Hematol Blood Transfus. 2018;34(2):204-15.

Prevalence of Anaemia in Pregnant Women. World Health Organization. Available at: https://www.who.int/data/gho/data/indicators/indicator-details/GHO/prevalence-of-anaemia-in-pregnant-women-(-). Accessed on 20 January 2022.

Garzon S, Cacciato PM, Certelli C, Salvaggio C, Magliarditi M, Rizzo G. Iron deficiency anemia in pregnancy: Novel approaches for an old problem. Oman Med J. 2020;35(5):e166.

Means RT. Iron deficiency and iron deficiency anemia: Implications and impact in pregnancy, fetal development, and early childhood parameters. Nutrients. 2020;12(2):447.

Moety GAF, Ali AM, Fouad R, Ramadan W, Belal DS, Haggag HM. Amino acid chelated iron versus an iron salt in the treatment of iron deficiency anemia with pregnancy: A randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2017;210:242-6.

Makled AK, Abuelghar WM, El-Shahawy AA, Elshazly M. Amino acid chelated iron versus ferrous fumarate in the treatment of iron deficiency anemia with pregnancy: Randomized controlled trial. 2020;10(1):95-103.

Santiago Ma A, Reyes LD, Olivar JU. Comparison of the efficacy of iron amino acid chelate and ferrous sulfate in the treatment of iron deficiency anemia among pregnant women seen at the out-patient department of a tertiary medical center on 2016-2017. Phil J Obstet Gynecol. 2018;42(6):1-15.

Zargaran M, Saadat E, Dinarvand R, Sharifzadeh M, Dorkoosh F. Preparation and bioavailability analysis of ferrous is alanine chelate as a new micronutrient for treatment of iron deficiency anemia. Adv Pharm Bull. 2016;6(3):407-13.

Gómez-Ramírez S, Brilli E, Tarantino G, Muñoz M. Sucrosomial® iron: A new generation iron for improving oral supplementation. Pharmaceuticals (Basel). 2018;11(4):97.

Sharma JB, Nagabhushan KH. Efficacy of ferrous bisglycinate (FeroseTM) in anemia during pregnancy. J Pharm Res. 2012;5(5):2881-2.

Peña-Rosas JP, De-Regil LM, Garcia-Casal MN, Dowswell T. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015;(7):CD004736.

Anaemia mukt bharat 6x6x6 strategy. Available at: https://anemiamuktbharat.info/home/6x6x6-strategy/. Accessed on 20 January 2022.

Milman N. Oral iron prophylaxis in pregnancy: not too little and not too much! J Pregnancy. 2012;2012:514345.

Singh S, Singh S, Lata S, Jain R, Bissa U, Ramanidevi T, et al. Evaluation of efficacy and tolerability of ferrous bisglycinate tablets in comparison with ferrous sulphate tablets in patients with iron deficiency anemia. Semantic Scholar. 2016.

Valenzuela C, Olivares M, Brito A, Hamilton-West C, Pizarro F. Is a 40 % absorption of iron from a ferrous ascorbate reference dose appropriate to assess iron absorption independent of iron status? Biol Trace Elem Res. 2013;155(3):322-66.

Milman N, Jønsson L, Dyre P, Pedersen PL, Larsen LG. Ferrous bisglycinate 25 mg iron is as effective as ferrous sulfate 50 mg iron in the prophylaxis of iron deficiency and anemia during pregnancy in a randomized trial. J Perinat Med. 2014;42(2):197-206.

Ashmead HD. The absorption and metabolism of iron amino acid chelate. Arch Latinoam Nutr. 2001;51(11):13-21.

Singhal SR, Kadian V, Singh S, Ghalaut V. Comparison of Various Oral Iron Salts in the Treatment of Iron Deficiency Anemia in Pregnancy. Indian J Obstet Gynecol Res. 2015;2(3):155-8.

Name JJ, Vasconcelos AR, Valzachi Rocha Maluf MC. Iron Bisglycinate Chelate and Polymaltose Iron for the Treatment of Iron Deficiency Anemia: A Pilot Randomized Trial. Curr Pediatr Rev. 2018;14(4):261-8.




How to Cite

Chandra, S., Mohanty, S. N., Gupta, M., Purohit, V., & Parekar, R. (2022). Evaluation of safety and tolerability of iron amino acid chelate therapy in pregnant women. International Journal of Basic & Clinical Pharmacology, 11(3), 249–254. https://doi.org/10.18203/2319-2003.ijbcp20221040



Original Research Articles