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Trial registered on ANZCTR


Registration number
ACTRN12618000960257
Ethics application status
Approved
Date submitted
22/05/2018
Date registered
7/06/2018
Date last updated
7/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Iron Supplementation and Nutritional Education in Palestinian Adolescents
Scientific title
Effects of Iron Supplementation and Nutritional Education Among Iron Deficinecy Anemia and Iron Deficient Female Adolescents in The Gaza Strip Palestine
Secondary ID [1] 294965 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
iron deficiency 307964 0
iron deficient anemia 307965 0
Condition category
Condition code
Diet and Nutrition 306998 306998 0 0
Other diet and nutrition disorders
Blood 307177 307177 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly iron supplementation (Ferrous Fumarate 200 mg) will be administered
for 3 months while the nutritional education will be 3 months as well. The percentage of
iron in ferrous fumarate 200 mg is 33%, which mean contain 66 mg elemental iron per
tablet. The guidelines used by WHO of iron supplements to treat IDA recommended 60
mg iron daily. The same guidelines reported that the efficacy of once or twice/weekly
supplementation in adolescents group appears promising, and the operational efficiency
of intermittent dosing regimens is being evaluated. Group A received iron tablets and Group B received nutrition education.

Strategies to monitor adherence include unused tablet return and to calculate total number of iron pills intake by particular participants). Compliance will be measured via :

Compliance % (Group A) = Total no. of iron pills intake by participants X 100% Total no. of supposed no. of pills.

Whereby, for Group B, it is based on attendance records. This sheet will be used for the subjects in the nutritional educational group B to indicate the number of session attended by a particular students.

Compliance % (Group B) = Total no. of sessions attendant by participants X 100% Total no. of sessions delivered

All participants will also need to report their health status by doing weekly health recall. This is to monitor the changes observed during the intervention, as well as side effects, such as constipation, diarrhea, nausea or vomiting, abdominal or stomach pain cramping (continuing) or soreness.
Intervention code [1] 301292 0
Prevention
Comparator / control treatment
Nutrition Education Group
Control group
Active

Outcomes
Primary outcome [1] 305984 0
Anemia status will be assessed by measuring hemoglobin (Hb) concentration using a Sysmex XE-2100 hematology analyzer; Calibration of the device will checked daily using control solutions provided by the manufacturer. The result will be recorded as hemoglobin in grams per deciliter, each sample will be analysed in duplicate. Anemia will be defined according to WHO guidelines as Hb < 12.0 g/dl, mild anemia as Hb 9.0-< 12.0 g/dl, moderate anemia as Hb <90 g/dL, and severe anemia as Hb < 70 g/dl.
Timepoint [1] 305984 0
Baseline and 3 months
Secondary outcome [1] 347208 0
Iron status :
Iron status will be assessed by measuring serum ferritin and determined by enzyme linked immunosorbent assay (ELISA) by (Human Ferritin ELISA Kit-Sigma-Aldrich-Germany) in duplicate and the average results will be recorded
Timepoint [1] 347208 0
baseline and 3 months
Secondary outcome [2] 347666 0
Malonyledialdehyde (MDA) will be measured by thiobarbituric acid (TBA) method seems to be most suitable method because of its high sensitivity (Kei 1978).
Timepoint [2] 347666 0
Baseline and 3 months
Secondary outcome [3] 347669 0
C-reactive protein (CRP) is a sensitive marker of systemic inflammation that synthesized by the liver. CRP is a nonspecific acute-phase reactant that has traditionally used to detect acute injury infection and inflammation (Backes et al. 2004). C-reactive protein (CRP) will be measured from the serum of participants as an indicator of infection or inflammation, which can affect hemoglobin and serum ferritin concentrations, by latex-enhanced immunonephelometry on a BN II Analyzer (Dade Behring, Newark, DE). A cutoff value of > 6 mg/L will be used (Schneider 1973).
Timepoint [3] 347669 0
Baseline and 3 months
Secondary outcome [4] 347670 0
The knowledge questionnaire will be used to evaluate the knowledge in management of iron deficiency anaemia among adolescent female (Sichert-Hellert et al. 2011). A planned teaching programme will be prepared on anemia, iron deficiency anaemia, and risk factors that causes its.
Timepoint [4] 347670 0
Baseline and 3 months

Eligibility
Key inclusion criteria
1. Students who diagnosed iron deficient and iron deficient anemic.
2. Students who iron deficient non-anemic, mild anemic or moderate iron
deficient anemic.
Minimum age
13 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Student who diagnosed anemic but have normal ferritin level.
2. Students who iron deficient severe anemic (Hb. < 7.0 g/dl).
3. White blood cells (WBC) above normal range.
4. Students who are diagnose underweight.
5. Students who have anemia either than iron deficiency anemia.
6. Students who are under medication

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Statistical package for social science (IBM-SPSS) version 22 will be used for analysis
of data, which will be conducted as follow:
1. Review of the filled questionnaire, Coding the questions, Data entry, Data
cleaning, and coding variable.
2. Descriptive statistics including frequencies, percentages, mean, median,
confidence interval (CI), interquartile range (IQR) and standard deviation.
36
3. Chi-square distribution to determine the association between categorical
variable like: parents education, parent employment, family size …etc.
4. Univariate analysis, after assumption of normality, parametric test like t-tests,
one way ANOVA, and non-parametric tests like; Mann-Whitney test, Kruskal
Wallis test to compare continuous variables like hemoglobin, ferritin, and IQ.
5. Bivariate analysis after assumption of normality to identify the relationships
between continuous variable like; Spearman, Pearson and simple linear
regression.
6. Multivariate analysis; Odd ratio OR CI determine by conditional logistic
regression of association of risk factors associated with anemia and IDA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
1/10/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
126
Accrual to date
Final
126
Recruitment outside Australia
Country [1] 10495 0
Palestinian Territory, Occupied
State/province [1] 10495 0
Gaza

Funding & Sponsors
Funding source category [1] 299554 0
Self funded/Unfunded
Name [1] 299554 0
Razinah Sharif
Country [1] 299554 0
Malaysia
Primary sponsor type
Individual
Name
Razinah Sharif
Address
Program of Nutritional Sciences, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 298858 0
Individual
Name [1] 298858 0
Marwan O Jalambo
Address [1] 298858 0
Palestine Technical College, Deir-al Balah, Gaza Palestine
Country [1] 298858 0
Palestinian Territory, Occupied
Secondary sponsor category [2] 298860 0
Individual
Name [2] 298860 0
Ihab Naser
Address [2] 298860 0
Al-Azhar University-Gaza
Jamal Abdl Naser St.
Gaza, Gaza Strip
Palestine
Gaza P.O Box 1277
Country [2] 298860 0
Palestinian Territory, Occupied

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300451 0
Research & Ethics Commitee Universiti Kebangsaan Malaysia & Palestinian Health Board (Helsinki Committee)
Ethics committee address [1] 300451 0
Hospital Canselor Tuanku Muhriz
Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM)
Jalan Yaacob Latif
Bandar Tun Razak
56000 Cheras, Kuala Lumpur Malaysia.
Ethics committee country [1] 300451 0
Malaysia
Date submitted for ethics approval [1] 300451 0
21/02/2015
Approval date [1] 300451 0
01/06/2015
Ethics approval number [1] 300451 0
Ethics committee name [2] 300452 0
Helsinki Commitee
Ethics committee address [2] 300452 0
Palestinian health Research Council
Ethics committee country [2] 300452 0
Palestinian Territory, Occupied
Date submitted for ethics approval [2] 300452 0
01/12/2014
Approval date [2] 300452 0
02/02/2015
Ethics approval number [2] 300452 0
PHRC/HC/3/14

Summary
Brief summary
Iron deficiency (ID) is the most common form of malnutrition worldwide, affecting
more than 2000 million people globally. Iron deficiency anemia (IDA) is highly
widespread in developing countries. Adolescent female constitute about fifth of total
female population in the world. Adolescent is one of the most challenging period in
human development. The sudden changes create nutritional needs. As a period of
growth and development, is considered the best time to intervene, to assist in physical
and mental development, and to prevent later maternal anemia. The prevalence
estimates of IDA among adolescents is 30–55% worldwide. Adolescence is an
opportune time for interventions to address anaemia. Not only is there a need (growth,
preparation for pregnancy), but large numbers of both male and female adolescents can
be reached easily if school attendance or participation in other group activities is high.
Also, adolescents are open to new information and new practices since they are often
striving for physical or academic excellence. The present study designed to determine
the prevalence of anemia, ID and IDA and to study the efficacy of iron-supplementation
and nutritional education on hemoglobin and ferritin levels among female adolescents
aged 15-19 years living in the Gaza strip-Palestine. The study has two phases: the first
phase will be a cross sectional descriptive study, which will enroll randomly 374 female
students aged 15-19 years in the Gaza strip-Palestine. The study population in the study
is female students enrolled in the secondary schools. Five female secondary schools
will be selected randomly from five governorates in the Gaza strip. In each school, one
to two classes of each grade will be selected randomly as well. According to the list of
the student’s names, the subjects will be selected upon odd number in the school
records. The second phase is randomized controlled trial (intervention phase) that will
be divided into three groups; the first group for iron supplementation, the second for
nutritional education intervention and the last as control group. Data will be collected
by questionnaires, anthropometric measurements, complete blood counts (CBC) and
serum ferritin will be analysed. All ID and iron deficient anemic female adolescents
will be monitored to evaluate the effectiveness of iron supplement and nutritional
education. Statistical package for social science (IBM-SPSS) version 22 will be used
for analysis of data.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2739 2739 0 0
/AnzctrAttachments/375162-Marwan Jalambo Proposal.pdf (Protocol)
Attachments [2] 2740 2740 0 0
/AnzctrAttachments/375162(v22-05-2018-15-23-35)-Marwan Jalambo Proposal.pdf (Ethics approval)
Attachments [3] 2755 2755 0 0
/AnzctrAttachments/375162-WhatsApp Image 2018-05-22 at 1.51.25 PM.pdf (Ethics approval)

Contacts
Principal investigator
Name 83706 0
Dr Razinah Sharif
Address 83706 0
Program of Nutritional Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 83706 0
Malaysia
Phone 83706 0
+60392897459
Fax 83706 0
Email 83706 0
razinah@ukm.edu.my
Contact person for public queries
Name 83707 0
Dr Razinah Sharif
Address 83707 0
Program of Nutritional Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 83707 0
Malaysia
Phone 83707 0
+60392897459
Fax 83707 0
Email 83707 0
razinah@ukm.edu.my
Contact person for scientific queries
Name 83708 0
Dr Razinah Sharif
Address 83708 0
Program of Nutritional Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 83708 0
Malaysia
Phone 83708 0
+60392897459
Fax 83708 0
Email 83708 0
razinah@ukm.edu.my

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