None listed
Conditions
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.
Interventions
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 efficie
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.
Sponsors
Razinah Sharif
Study design
Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Healthy volunteers
No
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.
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
Outcome results
None listed