A Phase 3 interventional study of Iron Supplement Tablets in Anemia and Iron Deficiency Anemia, sponsored by Universitas Sriwijaya. Completed at 1 site in Indonesia. Open to female participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Universitas Sriwijaya · Phase 3, Interventional, and Prevention
The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. The main questions it aims to answer are:
a To identify information for the development of a local culture-based nutrition education model and to build a ready-to-implement local culture-based nutrition education model.
b. To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency.
c. To test the impact of the local culture-based nutrition education model on the improvement of knowledge, attitude, and IST consumption compliance among female adolescents.
Participants will received IST and local culture-based nutrition education. Researchers will compare control group received IST as the Ministry of Health's program for the prevention of anemia with a subsidy for providing IST
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 126 is above the median of 96 across 1,318 interventional studies indexed under Anemia.
Browse Anemia studies →Universitas Sriwijaya is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Dietary Supplement: Iron Supplement Tablets
Dietary Supplement: Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education
Educational Intervention
The local culture to be used was based on the results of a qualitative study conducted prior to the intervention, where Kelakar Betok is the local culture preferred by female adolescents, used as a means of nutrition education. Subsequently, the social media used in nutrition education publicity is Instagram. Nutrition education is provided in the form of educational videos based on local culture broadcasted through the Instagram account @remaja.bebasanemia.
Time frame: 12 Weeks
Iron Supplement Tablet (IST) Administration
The IST used as an intervention consists of IST containing 60 mg FeSO4 and 400 mcg of folic acid, which is a government program. The program policy for administering IST to female adolescents is carried out once a week in the year, which was given in a blanket approach. This supplementation was carried out at educational institutions. The schools that receive iron tablets are Junior High Schools and Senior High Schools
Time frame: 16 Weeks
Plan to share: Undecided — Study Protocol Statistical Analysis Plan (SAP)
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Jan 2022, 6 months.
Of 58 non-industry phase 3 interventional studies under Anemia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's 6 months is below that.
Counting every sponsor, half of 167 studies reached it within 24 months; a quarter within 15 and three quarters within 49.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron Supplement
Universitas Sriwijaya