Effect of iron folic acid with tablet vitamin C compared to iron folic acid with routine verbal advice of vitamin C rich foods on the hemoglobin levels of anemic pregnant women attending a tertiary care hospital in Puducherry: protocol for a pragmatic trial

Authors

  • Alyssa M. Prince Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
  • Jayalakshmy Ramakrishnan Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
  • Prabhu M. Department of Pathology, Institute of Postgraduate Medical Education and Research, Puducherry, India
  • Vignesh Loganathan Department of Preventive and Social Medicine, Institute of Postgraduate Medical Education and Research, Puducherry, India
  • Latha Chaturvedula Department of Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20232198

Keywords:

IFA , Vitamin C, Anemia, Pregnancy

Abstract

Background: In routine practice, pregnant women are advised to take iron folic acid (IFA) tablets with vitamin C-rich foods. If vitamin C tablets are given instead, there may be an improvement in the hemoglobin levels of pregnant women. The study aims to find the effectiveness of IFA tablet with vitamin C tablet compared to IFA tablet with verbal advice of vitamin C rich foods, over 6 weeks, on the hemoglobin levels of anemic pregnant women (13-33 weeks) attending a tertiary care hospital in Puducherry.

Methods: A pragmatic trial will be conducted in the antenatal OPD of a hospital in Puducherry. Anemic pregnant women will be consecutively recruited until a sample size of 86 is attained. Permuted block randomization and allocation concealment will be used. After eligibility assessment, participants will be randomly assigned two arms. The intervention arm will receive IFA tablets with vitamin C tablets, while the control arm will be advised to take IFA tablets with vitamin C-rich food. Participants will be followed up at 6 weeks. The intention-to-treat approach will be used. Linear regression will be performed followed by multivariable linear regression to adjust for confounding variables.

Conclusions: This study protocol is designed to investigate whether the hemoglobin status and control of anemia in anemic mothers can be improved by giving IFA tablets with vitamin C tablets in routine practice, rather than verbal advice to take IFA tablets with vitamin C-rich foods.

Metrics

Metrics Loading ...

References

Li Q, Liang F, Liang W, Shi W, Han Y. Prevalence of anemia and its associated risk factors among 6-months-old infants in Beijing. Front Pediatr. 2019;7(7):1-7.

World Health Organziation. Anaemia in women and children. The global health observatory. Available at: https://www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children#:~:text=Summary findings&text=In 2019%2Cglobalanaemiaprevalence,womenaged15-49years. Accessed on 25 June, 2023.

International Institute for Population Sciences. National Family Health Survey - 5 2019-21. Minist Heal Fam Welf. 2020;361:2.

Sifakis S, Pharmakides G. Anemia in pregnancy. Ann N Y Acad Sci. 2000;900:125-36.

Interventions of the Anemia Mukt Bharat Programme. Available at: https://anemiamuktbharat.info/home/interventions/. Accessed on 25 June, 2023.

De-Regil DLM, Peña R, Juan Pablo Gulmezoglu M, Martines J, Matthews M, Rogers L. Guideline : Daily iron and folic acid supplementation in pregnant women. World Heal Organ. 2012;32.

Richard Hurrell IE. Iron bioavailability and dietary reference values. Am J Clin Nutr. 2010;91(1):1461S-7.

Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000;42(3):241-7.

Lavanya P, Jayalakshmy R, Rajaa TM. Adherence to iron and folic acid supplementation among antenatal mothers attending a tertiary care center, Puducherry: A mixed‑methods study. J Fam Med Prim Care. 2020;9(10):5205-11.

Downloads

Published

2023-07-26

How to Cite

Prince, A. M., Ramakrishnan, J., M., P., Loganathan, V., & Chaturvedula, L. (2023). Effect of iron folic acid with tablet vitamin C compared to iron folic acid with routine verbal advice of vitamin C rich foods on the hemoglobin levels of anemic pregnant women attending a tertiary care hospital in Puducherry: protocol for a pragmatic trial. International Journal of Clinical Trials, 10(3), 250–253. https://doi.org/10.18203/2349-3259.ijct20232198