Nutrition 31 (2015) 1358–1361

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Nutrition
journal homepage: www.nutritionjrnl.com

Applied nutritional investigation

Efficacy of zinc sulfate supplement on febrile seizure recurrence

prevention in children with normal serum zinc level:
A randomised clinical trial
Razieh Fallah M.D. a, Saeideh Sabbaghzadegan M.D. b,
Sedighah Akhavan Karbasi M.D. c, Fariba Binesh M.D. d, *
a
Pediatric neurologist, Associate Professor, Department of Pediatrics, Growth Disorders of Children Research Center, Shahid Sadoughi University
of Medical Sciences, Yazd, Iran
b
Interne, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
c
Pediatrician, Associate Professor, Department of Pediatrics, Growth Disorders of Children Research Center, Shahid Sadoughi University of
Medical Sciences, Yazd, Iran
d
Pathologist, Associate Professor, Department of Pathology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

a r t i c l e i n f o a b s t r a c t

Article history: Objective: Serum zinc level might be related to pathogenesis of febrile seizure (FS). The purpose of
Received 1 March 2015 this study was to evaluate efficacy and safety of oral zinc supplementation on FS recurrence pre-
Accepted 25 May 2015 vention in non-zinc-deficient children.
Materials and Methods: In a randomized clinical study, one hundred 18 to 60 mo old children with
Keywords: normal zinc level with first simple FS were referred to Shahid Sadoughi Hospital, Yazd, Iran from
Febrile seizure
May 2012 to June 2013, were randomly assigned to two groups to receive 2 mg/kg/d zinc sulfate for
Febrile seizure recurrence
six consecutive months or placebo as control group and were followed up for 1 y for FS recurrence.
Zinc sulfate
Child Results: 41 girls and 59 boys with mean age of 2.47
1.01 y were evaluated. Race, mean weight,
Prevention height and body fat were similar in both groups. FS recurrence occurred in 19 children (38%) in the
control group [95% confidence interval (CI): 19.45%–53.95%] and in 11 children (22%) in the zinc
sulfate (95% CI: 57.47%–89.13%) groups, respectively; and the zinc group had lower FS recurrence
(P ¼ 0.03). The mean serum zinc level before intervention was lower in children with FS recurrence
(72.43
14.58 mg/dL versus 96.33
12.69 mg/dL, P ¼ 0.04).
Gastrointestinal side effects (vomiting in five children, heartburn in two children and abdominal
pain in one child) were seen in 16% of the zinc group and vomiting occurred in two children (4%) in
control group and frequency of adverse events was similar in the two groups (P ¼ 0.1).
Conclusion: Zinc supplementation should be considered as effective and safe in prevention of FS
recurrence.
Ó 2015 Elsevier Inc. All rights reserved.

Introduction major concern of parents of children with first FS is the risk of

Febrile seizure (FS) is defined as a seizure associated with a
febrile illness in the absence of central nervous system infections
or acute electrolyte abnormalities in 6 to 60 mo old children
without previous afebrile seizures, and is the most common type
of seizures in children, occurring in 2 to 5% of them. FS is divided
into simple (benign) and complex types. Complex FS is defined as
a seizure lasting longer than 15 min, recurring within 24 h. One
* Corresponding author. Tel.: þ00 98 35 182 24000; fax: þ00 98 35 182 24100.
E-mail address: binesh44@yahoo.com (F. Binesh).
http://dx.doi.org/10.1016/j.nut.2015.05.024
0899-9007/Ó 2015 Elsevier Inc. All rights reserved.
recurrence and the most important factor which increases febrile
convulsion recurrence rate is occurrence of first FS at an age of
less than 1 year. Other major risk factors for recurrence of FS are
duration of fever in less than 24 h and 38 to 39 C fever. Minor
risk factors for recurrence of FS are positive family history of FS,
family history of epilepsy, Complex FS, day care, male sex, and
lower serum sodium [1].
The pathogenesis of febrile convulsion is undetermined and
factors such as genetic predisposition, fever-associated synchro-
nized neuronal activity of brain ion channels changes, neuro-
transmitters imbalance, reduction in inhibitory neurotransmitter

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 R. Fallah et al. / Nutrition 31 (2015) 1358–1361 1359

of gamma-amino butyric acid (GABA) and change in trace elements
level might be contributing factors [2,3].
“Zinc is a trace element that has a critical role in cell division,
protein synthesis, wound healing and immune function and it is
estimated that 25% of the world population is at risk of zinc
deficiency [4].”
Based on results of some studies, blood and cerebrospinal
fluid zinc level of children with febrile seizure was significantly
lower than in children with afebrile seizure. Zinc level has an
important role in level of gamma-amino-butyric acid (GABA) as
the main inhibitory neurotransmitter of brain. Zinc stimulates
pyridoxal kinase enzyme activity and decarboxylation of gluta-
mic acid and increases brain GABA level and also prevents the
excitatory neuronal discharge. Therefore, decrease of serum zinc
level and GABA levels might play a role in the pathogenesis of FS
[5–9].
In both groups, children were followed up every 3 mo for 1 year for the
recurrence of FS, timing of recurrence and side effects. The intervention was
delivered by mothers and primary and secondary outcomes were assessed by the
intern of research who was not informed of the drug group assignment.
The primary endpoint was FS recurrence and secondary endpoint was clinical
side effects.
The data were analyzed using Statistical Package for the Social Sciences
version 17 (IBM SPSS Statistics, Armonk, NY, USA) statistical software. Chi-square
test was used for data analysis of qualitative variables and mean values were
compared using independent Student’s t test. The Kaplan-Meier method was
used to calculate the probability of recurrence of FS during follow-up. Differences
were considered significant at P values of less than 0.05.
Informed consent was taken from the children’s parents before the admin-
istration of the drugs and the study approved by the Ethics Committee of Shahid
Sadoughi University of Medical Sciences, Yazd, Iran.
This study is registered in Iranian clinical trials with registration number:
IRCT201211262639 N9 and the researchers got no support from the drug
company.
Results

Theory/calculation
The design and conduct of this trial was straightforward, and
we did not have any losses during follow-up, nor exclusions. 41
It is hypothesized that zinc supplementation in children with
girls and 59 boys with mean age of 2.47
1.01 y were followed
febrile convulsion might decrease recurrence of febrile seizure
up in two groups.
and the purpose of present research was to evaluate efficacy and
Comparison of some characteristics of the children is shown
safety of oral zinc supplementation on febrile seizure recurrence
in Table 1, which indicates no statistically significant differences
in non-zinc-deficient children in Yazd, Iran.
were seen from viewpoints of sex, family history of FS, family
history of epilepsy, mean age, mean height, weight, body mass
Materials and methods index (BMI), weigh in kg/height in m2, temperature at admission,
duration of fever before FS, duration of seizure, serum sodium,
In a randomized single-blind clinical, parallel group study, all consecutive 18
hemoglobin, ferritin, and zinc levels at the start of the study in
to 60 mo old referred children with first febrile seizure to Shahid Sadoughi
Hospital, Yazd, Iran from May 2012 to June 2013 were enrolled in the study. both groups.
Sample size was assessed to be 50 children in each group based on Z formula Thirty-two children had febrile seizure recurrence, with a
and a CI of 95% with 80% power to detect a 25% difference in febrile seizure mean occurrence time of 6.3
3.7 mo. The cumulative per-
recurrence between the two groups with type one error (alpha) of 0.05.
centage of FS recurrence, according to the Kaplan-Meier method,
Eligible participants included children ages 18 to 60 mo, with first simple FS,
their weight and height were above the third percentile on a standard growth
was 15.6% at 1 mo, 56.3% at 6 mo, and 90.6% at 1 year.
curves of National Health and Nutrition Examination Survey III (NHANES III) Recurrence of febrile seizure occurred in 19 children (38%) in
curves [10] and with normal serum zinc level (plasma level of 70-158 mg/dL) [11] the control group (95% CI: 19.45% to 53.95%) and in 11 children
were measured by coupled plasma mass spectrometry within the first 2 h after
the first FS attack.
Exclusion criteria consisted of receiving a zinc combination or supplemen- Table 1
tation within the past 2 mo, central nervous system infections, history of pre- Comparison of selected characteristics of children in both groups
vious febrile or afebrile seizure, neurodevelopmental delay, presence of any
chronic systemic diseases (endocrine, cardiac, renal, metabolic, malignancy, Data Placebo Zinc sulfate P value
rheumatologic, etc), iron deficiency, and iron deficiency anemia (anemia was Sex
defined as hemoglobin level of less than 10.5 g/dL in 18 mo to 2 y and less than Girl 19 22 0.5
11.5 g/dL in 2 to 6 y and iron deficiency was defined as serum ferritin level of less Boy 31 28
than 12 ng/mL if CRP was negative or 1þ, ferritin level of less than 30 ng/mL if CRP Family history of febrile seizure
was 2þ, or serum iron levels of less than 22 mg/dL) [12]. Yes 10 12 0.6
Children who were underweight (weight below the third percentile on a No 40 38
standard growth curve), short stature (height of less than two standard deviation Family history of epilepsy
from height) based on NHANES III [10] zinc deficient (plasma level less than Yes 7 6 0.9
70 mg/dL) [11], or had severe malnutrition, were excluded. No 43 44
Developmental status of children was assessed using the Denver II Devel- Age in year (mean
SD) 2.37
0.93 2.58
1.07 0.3
opmental Screening Test by the pediatric neurologist of research. Weight in kg (mean
SD) 12.89
2.12 13.11
1.43 0.9
The patients were weighed using a digital scale with a sensitivity of Height in centimeter (mean
SD) 87.14
7.68 86.12
9.71 0.7
100 grams while wearing little or no outer clothing. The crown-heel height was Body mass index (mean
SD) 18.54
7.61 19.43
8.97 0.4
measured by stadiometer to the nearest millimeter. The weighing scale and Temperature at admission in 38.66
0.68 38.54
0.61 0.4
stadiometer were products of Seca (Hamburg, Germany) and all measurements centigrade (mean
SD)
were done by one researcher. Duration of fever before 17.34
3.89 13.83
2.07 0.3
Children in both groups were from Yazd, Iran and their race/ethnicity, so- FS in hour (mean
SD)
cioeconomic status, diet, and the consumption of zinc-rich foods were similar. Seizure duration in minutes 7.24
4.8 6.78
4.5 0.6
The trial used computer generated equal simple randomization by random (mean
SD)
numbers and allocation ratio was 1:1 for the two groups. Serum sodium level in 139.1
9.48 141.2
10.69 0.7
Randomization and blinding was done by an investigator with no clinical meq/lit (mean
SD)
involvement in the trial. Data collectors, outcome assessors and data analysts Hemoglobin level in g/dL 11.44
1.21 11.34
1.56 0.9
were all kept blinded to the allocation. (mean
SD)
The children were randomized to receive daily supplementation of single Serum ferritin in ng/mL 54.51
11.33 55.32
10.26 0.8
dose of 2 mg/kg (maximum 50 mg) zinc sulfate for six consecutive months (mean
SD)
(Group I) or placebo as control group (Group II). Appearance and taste of zinc and Zinc level at the start of the 84.67
12.34 81.73
13.35 0.5
placebo syrups were identical and the bottles were coded, known only to the study in mg/dL (mean
SD)
pediatric ward nurse.

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1360 R. Fallah et al. / Nutrition 31 (2015) 1358–1361

Table 2 frequent in children with FS [13–15]; and in other research,

Frequency of febrile seizure recurrence based on Select characteristics serum and cerebrospinal fluid zinc levels of children with FS
Febrile seizure recurrence Yes No P value were significantly lower than in children with febrile illness and
Sex afebrile seizure [5–9,16].
Girl 11 30 0.001 Zinc is one of the most abundant trace elements in the body,
Boy 21 38 with high levels observed in human brains, and is required for
Family history of febrile seizure
cellular metabolism, cell differentiation, normal central nervous
Yes 8 14 0.01
No 24 54 system development, neurologic functions, GABA receptor
Family history of epilepsy modulation, and nerve impulse transmission [5].
Yes 7 6 0.001 Foods rich in zinc include meat, shellfish, whole grains, le-
No 25 62 gumes, and cheese. Diets rich in phytates impair zinc absorption
Age in year (mean
SD) 2.01
0.34 2.22
0.91 0.2
Serum zinc level before 72.43
14.58 96.33
12.69 0.04
due to its binding properties [17]. Since the body has no
intervention in mg/dL specialized zinc storage system, daily intake of zinc is required
(mean
SD) and zinc deficiency is one of the most common nutritional de-
ficiencies in developing countries. Up to 79% of people in south
Asia may suffer from zinc deficiency [11].
Decreased levels of zinc can reduce GABA brain level and
(22%) in the zinc sulfate (95% CI: 57.47% to 89.13%) groups, seizure threshold. Most research compares serum zinc level of
respectively. Statistical analysis showed children who received children with FS and febrile children, and concludes that serum
zinc sulfate supplementation had lower febrile seizure recur- zinc levels in children with FS is significantly lower than in
rence (P ¼ 0.03). febrile children in the same age group. Zinc levels can be regar-
Mean FS recurrence was not statistically significant different
ded as one of the predicting and contributing factors of febrile
in both groups (6.6
3.6 mo in control group versus 5.7
3.8 mo convulsion [18].
in the zinc sulfate group and P ¼ 0.5).
Only in one study in Qazvin, Iran, did the serum zinc levels of
Table 2 shows frequency of febrile seizure recurrence based 9 mo to 5 y old children with FS as compared to healthy age, sex,
on some characteristics and indicates that frequency of febrile
weight, height, and head circumference match those of the
convulsion recurrence was more frequent in boys than girls. control group and based on the results, The mean serum zinc
Children with positive family history of FS and those with a
level was lower in the case group and zinc deficiency (serum zinc
family history of epilepsy showed more FS recurrence than those level less than 70 mg/dL) was more frequent in children with FS
with negative family history of FS and negative family history of
(53.81% versus 9.6%) [19].
epilepsy and finally, children with FS recurrence had a lower One major concern of parents of children with first FS is the
initial serum zinc level than those without FS recurrence. How-
risk of recurrence, and the purpose of this research was to
ever, none of them had zinc deficiency. evaluate efficacy of oral zinc sulfate supplementation in the
Comparison of serum zinc level in both sexes and in different
prevention of FS recurrence in non-zinc-deficient 18 to 60 mo old
age groups is presented in Table 3, which shows that the mean children with simple febrile convulsion. The results show that
serum zinc level at the start of intervention was lower in girls
frequency of FS recurrence was lower in children who received
than boys and 18 to 24 mo old children had lower serum zinc 2 mg/kg/d zinc sulfate supplement for 6 mo, which is not in
levels than 25 to 48 mo and 49 to 60 mo old children. agreement to two other Iranian studies [20,21]. In a study in
No serious side effects were witnessed in the two groups. Ardabil, Iran, frequency of FS recurrence after first simple FS in 1
Gastrointestinal side effects including vomiting in five children, to 5 y old children who received 20 mg/d zinc sulfate for one year
heartburn in two and abdominal pain in one child were seen in as control group was not statistically different and the authors
16% of the zinc sulfate group. All of the side effects were well- concluded that zinc sulfate supplement could not decrease FS
tolerated and disappeared in 2 to 3 wk and supplementation recurrence and it may be related to insufficient serum zinc level,
continued. Vomiting occurred in two children (4%) in the control probably due to incorrect use of drug or secondary decrease of
group. No statistically significant differences were seen from a serum zinc level in the children [20]. In another study in Tabriz,
safety viewpoint between the two groups (P ¼ 0.1). Iran, FS recurrence rate after first simple FS in 1 to 4 y old chil-
dren who received 2 mg/kg/d zinc sulfate for one year as placebo
Discussion group was not statistically different [21].
Possible explanations for this discrepancy are differences in:
Febrile convulsion is the most common type of seizure in age of children and design of study. As in this study, serum zinc
children and change in trace elements level might be a and iron levels were measured before intervention, and only
contributing factor for pathogenesis of FS [2,3]. Some studies children with normal serum zinc and iron levels were enrolled in
showed iron deficiency and iron deficiency anemia were more the study.
Table 3
In this study, the mean serum zinc level before intervention
Comparison of serum zinc level In both sexes and In different age groups was lower in children with FS recurrence, in compliance with the
Ahmadabadi et al. study [20].
Serum zinc level at the start of the study in mg/dL P value
(mean
SD)
Results of this study can be viewed as being promising,
because they show that zinc supplementation should be
Sex
Girl 74.32
11.85 0.03 considered as effective and safe in prevention of FS recurrence.
Boy 89.56
12.24 In a Mollah et al. study in Dhaka, Bangladesh, serum and CSF
Age groups zinc levels of children with FS were lower than in non-febrile
18 to 24 mo 73.22
10.13 0.01 seizure children, and the authors also suggest prescribing zinc
25 to 48 mo 88.81
14.67
49 to 60 mo 92.23
13.76
supplements might be effective in prevention of febrile
convulsion [22].

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 R. Fallah et al. / Nutrition 31 (2015) 1358–1361
In this study, the use of a single dose of 2 mg/kg/d zinc sulfate
for six consecutive months was safe, well tolerated and without
serious or life threatening events, and only mild transient
gastrointestinal side effects (vomiting, heartburn and abdominal
pain) occurred in 16% of children. The most common adverse
events of zinc are nausea and abdominal pain and side effects
such as diarrhea, vomiting, and constipation have been reported.
The majority of these gastrointestinal side effects of zinc sul-
phate or acetate in children are uncommon and mild, and can be
handled by dosage change or spontaneous disappearance, and
zinc sulphate is considered to be generally safe and well-
tolerated [23–26].
Limitations of this study were its small sample size and the
short duration of follow up.
In conclusion, low serum zinc level can be considered one of
the predicting and contributing factors of febrile seizure, and
based on the results of present research, zinc sulfate supple-
mentation was effective and safe in prevention of FS recurrence
in non-zinc-deficient children. Therefore, it is suggested that
further studies be performed to compare serum zinc level of
children with febrile convulsion to healthy control, to compare
frequency of febrile seizure occurrence in zinc deficient children
to those with normal serum zinc level, and to evaluate efficacy of
zinc supplementation in prevention of FS occurrence in zinc
deficient and non-zinc-deficient children. It is worthwhile to
conduct other clinical trials with larger sample sizes and longer
follow up for further proof of zinc sulfate efficacy in prevention of
recurrence of febrile convulsion.
Acknowledgments
This study was funded by a grant from the Deputy for
Research of Shahid Sadoughi University of Medical Sciences,
Yazd, Iran. This study was a thesis presented for obtaining the
Medical Doctor (MD) degree by Saeideh Sabbaghzadegan.
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