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Indian Pediatr 2019;56:33-36 |
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Incidence of
Side-effects After Weekly Iron and Folic Acid Consumption Among
School-going Indian Adolescents
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Vani Sethi 1,
Shikha Yadav2,
Sutapa Agrawal2,
Neha Sareen2,
Nishtha Kathuria2,
Preetu Mishra1,
Jaipal Kapoor3
and Sushma Dureja3
From 1Nutrition Section, UNICEF India
Country Office, Lodhi Estate; 2Independent Consultant; and
3Ministry of Health and Family Welfare, Government of India;
New Delhi, India.
Correspondence to: Vani Sethi, Nutrition Section,
UNICEF India Country Office, 73 Lodhi Estate,
New Delhi 110 003, India.
Email: [email protected]
Received: November 08, 2017;
Initial review: March 28, 2018;
Accepted: October 13, 2018.
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Objective: To estimate incidence of side effects
after weekly iron and folic acid supplementation (WIFS) in Delhi and
Haryana. Methods: In this cross-sectional school-based study,
data were collected from 4,183 adolescents on WIFS consumption and side
effects experienced first time of receipt of WIFS (week 1), and in last
two consecutive weeks (week 2,3). Week 3 was 48 hours preceding the
survey. Results: WIFS consumption in week 1, 2 and 3 was 85%, 63%
and 52%, respectively. Side effects reported were highest in first week
(25%) and reduced to 7% (week 2) and 5% (week 3). Side effects most
reported were abdominal pain (80%) and nausea (10%). Adolescents (45%)
who faced a side-effect in week 1 did not consume WIFS in subsequent
week. Conclusion: Incidence of side effects was low, but it
affected compliance. Positive reinforcement to students who face side
effects requires strengthening by teachers.
Keywords: Adverse effects, Anemia, Iron supplementation,
Prevention.
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A nemia is a major public health problem among
Indian adolescents [1]. In January 2013, the Indian Government launched
the nationwide weekly iron and folic acid supplementation (WIFS) program
for adolescent boys and girls (age 10-19 years) attending
government/government-aided schools, and for out of school adolescent
girls [2]. Components of school-based WIFS program, when launched in
2013, included weekly administration of iron and folic acid (IFA) tablet
(100 mg elemental iron and 0.5 mg folic acid) and bi-annual helminthic
control (400 mg albendazole) along with nutrition and health education.
After preparatory activities, the nation-wide program roll-out began in
May-July, 2013 However, when WIFS was first time administered to
adolescents, there were huge setbacks in Delhi and Haryana states, where
the program was halted owing to mass hysteria triggered by media reports
of hospitalization of school-going adolescents owing to vomiting,
abdominal pain and nausea after consuming IFA tablets [3,4]. State
Program managers raised a need for local survey data on the incidence of
side effects as the only survey-based information available was from WHO
(2011), which reported that side-effects are expected in 5-20% of
children, and are mild (stomach- ache, nausea, and change in color of
stool) with little effect on compliance [5]. Hence, this study was
undertaken, when WIFS was re-launched in these states after a gap of
three months.
Methods
This survey was conducted between 15 and 30 September
2013 in Haryana, and 15-30 October 2013 in Delhi, Six districts, three
each in Delhi and Haryana, were selected in consultation with Ministry
of Health and Family Welfare. Criteria used was districts having highest
reported incidence of side-effects following implementation of WIFS in
schools when the program was first rolled out in May 2013 (Haryana) and
July 2013 (Delhi). From each state, 30 clusters (schools) were selected
utilizing 30-cluster probability proportional to size sampling
methodology. Written consent from the school authorities was obtained
prior to the survey. Verbal consent was obtained from adolescents for
participating in the survey.
Using maximum reported incidence of side effects of
20% from Delhi/Haryana in May/July, 2013 (from State Government Program
Reports), 15% relative precision, 95% confidence interval and design
effect of 3, estimated sample size calculated was 4,098 (2,049 per state
and 70 adolescents grade VI-XII (35 boys and 35 girls) from each cluster
(school).
Data were collected by 17 postgraduate nutritionists
trained in nutrition epidemiology. Information sought included
socio-demographics, WIFS consumption, protocol followed, and side
effects on first consumption (in May/July, 2013, considered as week 1)
and in last two weekly consumptions (last two consecutive weeks,
considered as week 2 and week 3). Height and weight was recorded using
standard methods [6]. BMI-for-age Z score were calculated using
WHO Anthroplus (version 1.0.4), with cut-off <-2 standard deviation (SD)
taken as thinness [7]. Associations of frequency of side-effects faced
with independent variables were examined using bivariate and binary
logistic regression.
Results
A total of 4,183 adolescents (1,980 boys and 2,203
girls) from grades VI to XII present in the school, were covered and
formed the analytical sample. Considering all three weeks, 23%, 26% and
42% adolescents consumed IFA once, twice and all three times.
In the first week i.e., first time when WIFS
day took place in May/July, 2013, 3568 (85%) of 4183 adolescents
reported consuming IFA tablets (Table I). Of those who
consumed IFA tablets (n=3568), 907 (25%) reported facing
side-effects. However, in week 2, only 2630 (63%) reported consuming IFA
– a drop from 85% in week 1. Of those who consumed IFA (n=2630),
only 195 (7%) reported side effects. A total of 410 out of the 907
adolescents (45%), who faced a side effect in first week did not consume
IFA tablets in week 2. In week 3, 2181 (52%) reported consuming IFA — a
further drop from 63% in second week. Reported incidence of side effects
lowered to 5%. Eighty out of 195 (41%) adolescents who faced a side
effect in second week did not consume IFA in week 3. Through the three
weeks, 1050 adolescents faced atleast one side effect (25%); of these,
88% faced it only once, 8% twice and only 4% reported facing a side
effect on all three consumptions. Most common reported side effects were
abdominal pain (80%), nausea (10%) and dizziness (8%).
TABLE I Consumption Pattern and Reported Side-effects in Three Weeks of Iron-Folic Acid
Supplementation in School-going Adolescents (N=4183)
Characteristics |
n (%) |
Reported consuming WIFS (in three consumptions asked)* |
Never |
406 (9.7) |
Once |
941 (22.5) |
Twice |
1071 (25.6) |
All three times |
1765 (42.2) |
Reported that WIFS was done in supervision of teacher**
|
1799 (43.0) |
Week 1 (First Consumption) |
Consumed WIFS |
2568 (85.3) |
Faced side effects |
907 (25.4) |
IFA discontinued in subsequent week |
410 (45.2) |
IFA continued in subsequent |
497 (54.8) |
Did not face side effects |
2661 (74.6) |
IFA discontinued in subsequent week |
694 (26.1) |
IFA continued in subsequent |
1967 (73.9) |
Week 2 |
Consumed IFA |
2630 (62.9) |
Faced side effects |
195 (7.4) |
IFA discontinued in subsequent week |
80 (41.0) |
IFA continued in subsequent |
115 (59.0) |
Did not face side effects |
2435 (92.6) |
IFA discontinued in subsequent week |
685 (28.1) |
IFA continued in subsequent |
1750 (71.9) |
Week 3 (most recent consumption) |
Consumed WIFS |
2181 (52.1) |
Faced side effects |
109 (5.0) |
Did not face side effects |
2072 (95.0) |
Details of side effects among those who faced (N=1050) |
Frequency |
|
Faced once |
928 (88.4) |
Faced twice |
85 (8.1) |
Faced on every consumption |
37 (3.5) |
Types |
Nausea |
100 (9.5) |
Dizziness |
80 (7.6) |
Abdominal pain |
838 (79.8) |
Black stool |
14 (1.3) |
Allergy |
13 (1.2) |
*First time, when the programme was launched in May/July,
and in last two weekly consumption days preceding the survey.
**most recent consumption. |
The odds of reporting side effects was higher among
girls compared to boys, in Delhi compared to Haryana, students who
chewed the tablet or took it empty stomach, and where positive
reinforcement by parent, teacher or peer was missing (Table II).
Being undernourished (BMI-for-age Z score <-2 SD) was not significantly
associated with reporting a side effect (Table II).
TABLE II Association of Programmatic Variables with Reporting of Side-effects
Independent variable |
Reported frequency of facing side effects in the 3 study
weeks (column %) |
P value |
OR (95% CI) |
|
None (2,7725) |
Once (n=926) |
≥ Twice (n=124) |
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|
State |
Haryana |
|
78.3 |
30.1 |
4.3 |
|
Delhi |
65.6 |
19.4 |
2.3 |
0.001 |
2.04 (1.6, 2.6) |
Gender |
Boys |
50.9 |
40.4 |
31.5 |
|
1.53 (1.3, 1.8) |
Girls |
49.1 |
59.6 |
68.5 |
0.001 |
|
Grade |
|
|
|
|
1.16 (0.9, 1.4) |
6-8 |
80.4 |
72.8 |
58.1 |
|
|
9-12 |
19.6 |
27.2 |
41.9 |
0.001 |
|
BMI-for-age Z-score |
|
|
|
|
|
>=-2SD |
73.6 |
72.8 |
75.0 |
|
|
<-2 SD |
26.4 |
27.2 |
25.0 |
0.53 |
|
Chewed the tablet |
No |
100 |
9.8 |
28.2 |
0.001 |
4.03 (2.3, 5.95) |
Yes |
0.0 |
89.2 |
71.8 |
|
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Taken WIFS empty stomach |
No |
16.8 |
21.7 |
20.2 |
|
|
Yes |
85.2 |
78.3 |
79.8 |
0.003 |
1.25 (1.01,1.5) |
Parental pressure to have WIFS |
Positive |
77.6 |
50.0 |
46.0 |
|
|
None |
22.4 |
50.0 |
54.0 |
0.001 |
2.8 (2.3,3.3) |
Teachers’ pressure to have WIFS |
Positive |
69.2 |
63.5 |
63.7 |
|
|
None |
30.8 |
36.5 |
36.3 |
0.003 |
1.3 (1.1,1.6) |
Peer pressure to have WIFS |
Positive |
70.1 |
52.3 |
51.6 |
0.001 |
1.3 (1.5, 1.8) |
Negative |
29.9 |
47.7 |
48.4 |
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Discussion
In this survey, we documented that following
school-based implementation of WIFS supplementation program, incidence
of side effects from first IFA tablet consumption was 25%, which reduced
gradually over three weeks (to 5% in week 3), but adversely affected
compliance as 45% of those who faced a side effect in first week did not
have the WIFS in subsequent week.
Not following the protocol was a significant
determinant of side-effects. Effective training of service providers,
parents and peer counselling has been instrumental in increasing
effectiveness of WIFS programs [8]. Teachers should be trained to ensure
students are equipped with information on types of side-effects,
counselled on what to do, whom to contact when such side-effects happen,
important helpline numbers to avoid panic, and also provide the tablet
under supervision. Despite not facing any side-effects in week 1, 26%
adolescents did not consume IFA in week 2, possibly owing to influence
of peers who faced a side-effect in first week and stopped taking WIFS
in subsequent weeks. Consumption of the tablet for mere programmatic
reasons may be considered following a meal as 79.8% of students who
reported side effects two or more times, had taken the tablet empty
stomach.
Incidence of side-effects following school-based WIFS
was low at week 3, the side-effects were mild, but they adversely
affected the compliance. The study urges for response mechanisms to
counter negative peer and parental pressure to be embedded within
program- implementation framework. Parents, Peers and teachers can play
a critical role to improve compliance of WIFS, despite the first
instance of experiencing a side-effect.
Contributors: VS, SD, JK: conceptualized
the study; SY,PM, NK: managed the field conduct and logistics; VS,PM,NS:
drafted the manuscript; SA: analyzed the data. All authors contributed
to the critical revision of the manuscript, and its final approval.
Funding: UNICEF, India Country Office;
Competing interest: None stated.
What This Study Adds?
• Side-effects adversely influenced
compliance to iron-folic acid consumption in a school-based
supplementation program owing to negative family/peer pressure.
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