STS 2024 Reference ID: STS 2024 - 12579

Awareness on iron-fortified food among women in suburban Madurai, Tamil Nadu and
assessment of the efficacy of iron-fortified rice among the same.

INTRODUCTION:

Anemia is a medical condition characterized by low hemoglobin resulting in an

inadequate capacity of blood to transport oxygen to meet the body’s physiology requirements.
One significant cause of anemia is iron deficiency, which is one of the components of
hemoglobin.

Iron deficiency results and this takes place in three stages. First, stored iron is depleted or used
up. Second, the amount of circulating iron in the blood falls. Third, insufficient iron is available
to be incorporated into hemoglobin and hemoglobin levels fall. Individuals falling into either of
the first two stages have iron deficiency (ID), while those in the third stage have iron deficiency
anemia (IDA).

There are two types of food iron—heme and non-heme iron. Both types of iron are found in flesh
food such as meat, fish, and poultry. Plant foods contain only non-heme iron. Iron rich food is of
high cost and are not affordable by all sections of society. Bioavailability of iron from iron-rich
sources and significantly less.

Enhancing nutritional value of food through fortification is a cost-effective approach to enhance

nutritional well-being of deficit populations with higher bioavailability and wider accessibility.
There is no need to change eating behavior, making it easy to implement and sustain on a large
or national scale because eating patterns are often traditional and deeply rooted in social culture
and are not always easy to change. The need for oral iron supplements will significantly be
lowered which is associated with nausea, vomiting, heartburn, abdominal pain, diarrhea, and
constipation.
Fortification of vitamin A and iodine has shown to increase the level serum retinol and median
urine iodine excretion respectively. This efficacy of fortification can be used to assess the
improvement in iron biomarkers by iron-fortified food, thus providing a cost-effective and
accessible food source.

OBJECTIVE:

1.To know whether the women of suburban Madurai are aware of the availability of iron
fortified food
 2.To create awareness about the same and educate them about the advantages of iron
fortified food

3.To estimate the prevalence of iron deficiency anemia in women of reproductive age (15-
44) of suburban Madurai.

4.To monitor improvements in iron biomarker levels after regular consumption of iron
fortified food in iron deficit women

5.To lessen the gap between easy availability of iron fortified food and their usage by
common people

METHODOLOGY:

Study Design: quasi-experimental design

Study type: Experimental study

Sampling technique: Multistage sampling technique

List of all women aged between 15 to 45 years will be taken and according to inclusion and
exclusion criteria subjects will be selected.

Through lottery method 100 people will be selected and tested for anemia.

Subjects will mild and moderate anemia (ICMR classification) are given iron fortified rice for3
months and their biomarkers are assessed before, at 6 weeks and after 12 weeks of intervention.

Sample size:
𝑍 2 𝑝𝑞
𝑒2

(1.96)2 (53.4)(46.6)
(10.6)2

The prevalence of anemia in non-pregnant reproductive age group women in Tamil Nadu
according to NFHS-5 is 53.4%, with precision of 20%, alpha error of 5%and confidence interval
of 95% the minimum sample size calculated 85 with 10% non- responsiveness rate the required
sample size is 93 which is rounded off to100.

Study center: Velammal medical college hospital and research institute

Study period: 3 months

Study population: Women of reproductive age group (15-45 years)

Inclusive criteria: The study includes

• Women of reproductive age group (15-45 years)

• With mild to moderate anemia (ICMR classifications)
● Mild Hb% 10–10.9 gm%
● Moderate Hb% 7–10 gm%
● Severe Hb% 4–7gm%
● Very severe: <4 gm Hb%

Exclusion criteria:

• Women with severe anemia (ICMR classification)

• History of other cause of anemia such as infections, chronic disease, malignancy
• Previously or presently under medications of iron supplements
• History of any comorbidities such DM, hypertension, hyperthyroidism, CKD
• Previously or presently under medication for other conditions
Proposed intervention:

The study will be conducted after obtaining informed consent from the subjects. Demographic
details, comorbidities, past history and treatment history of voluntary subjects is recorded.
Subjects are chosen after confirmation of grade of anemia using Point-of-care-testing (POCT)
device.

The data collection will be divided into two sections: section 1 (questionnaire) and section 2
(investigations). Section 1: A questionnaire is administered to the subjects to assess their
awareness on availability of iron fortified food in PDS (Public Distribution System) and iron
supplements that are available under national and state level schemes such as Anemia Mukt
Bharat, National Iron Plus Initiative (NIPI) and Weekly Iron Folic Acid Supplementation
(WIFS) and their levels of utilization of these programs. Awareness on efficacy and availability
of iron fortified food and available program will be given. They will be educated on the
advantage of iron fortified food over the regular food.

Section 2: Iron biomarkers are tested. There is no single test to diagnose ID or IDA Iron
biomarkers are preferred over hemoglobin. As a primary indicator, blood hemoglobin (Hb) is not
an adequate proxy indicator for iron status in developing countries where infections, including
inflammation and malaria, are common. This means that a combination of various biochemical
indicators of iron status such as Hb, serum iron, serum ferritin, transferrin saturation (that
requires measuring serum iron and total iron-binding capacity), TIBC (total iron binding
capacity) and UIBC (unsaturated iron binding capacity) must be used. The subjects will be
provided with iron fortified rice and their regular rice will be replaced. Daily iron intake is
calculated by taking a diet survey by 24 hours recall method and will be noted. Levels of iron
biomarkers in blood sample will be monitored after 6 weeks and 12 weeks and improvement in
their levels will be noted. Levels of hemoglobin measured to assess improvement of anemia. C-
Reactive protein (CRP) is also assessed to rule out acute infection at the time of study.

Data collection and instrumentation:

Identifying subject with anemia using Point-of-care-testing (POCT) device

Hemoglobin levels will be measured using invasive digital hemoglobinometer and instructions
given in the kit will be followed. The entire procedure is explained to the subjects prior to the
test. Subjects with mild to moderate (according to ICMR classification) are chosen

Iron biomarkers are assessed in peripheral venous blood sample

Iron Biomarker Before intervention After 6 weeks of After 12 weeks of

intervention intervention

Hemoglobin
Serum iron
Serum ferritin
Transferrin saturation
UIBC
TIBC
CRP (C-Reactive protein) will also be test along with iron biomarkers.

Ethics:

Study will be conducted after obtaining institutional ethical committee clearance.

Confidentiality:

The personal information of all participants will be maintained confidentially.

Statistical tool:

Data collected will be coded and entered in Microsoft excel. Analysis will be done using SPSS.

Categorical variables will be presented as frequencies and proportions, quantitative variables as

mean and standard deviation.

Association between the study outcome and its risk factor will be analyzed using Chi-square test.
To compare the means of participants before and after transfusion, paired T-test will be used.
The risk analysis will be done by logistic regression and expressed as odds ratio with 95%
confidence interval. P value <0.05 will be considered statistically significant.
Implication:

This study will create awareness on iron fortified food and existing national and state level
programs on anemia among suburban women of Madurai, Tamil Nadu. This will also educate
them about the advantages of iron fortified rice over normal rice. This will analyze the
improvement on levels of iron biomarkers on regular consumption of iron fortified food.
Monitoring levels of iron biomarkers at 6th and 12th week demonstrates the steady rise in iron
levels.

Hence this study provides an awareness about availability of cost-effective, easily accessible and
nutrient rich iron source with minimal side effects.

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