Tokyo, April 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061205) titled 'Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls: A Randomized Controlled Trial' on April 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - AUP

Condition: Condition - Nil Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effect of daily consumption of iron-fortified wheat flour on iron status, cognitive performance, inflammatory response, and immune markers among adolescent girls. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Interventions/Control_1 Interventions/Control_2 - Interventions/Control_2

Eligibility: Age-lower limit - 8 years-old

Gender - Female Key inclusion criteria - Female adolescents aged 12 to 18 years. Hemoglobin level between 8 and 12 g/dL (mild-to-moderate anemia). Resident in the study area for at least 6 months. Willingness to participate with written informed consent obtained from parents or guardians and assent from the adolescent participants. Key exclusion criteria - Severe anemia (hemoglobin < 8 g/dL). Chronic illnesses such as kidney disease, inflammatory disorders, or other conditions affecting iron metabolism. Current use of iron or other micronutrient supplements. Food allergies or dietary restrictions that prevent consumption of wheat or wheat-based products. Participation in other clinical trials or ongoing iron fortification programs. Target Size - 250

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 01 Month 01 Day Date of IRB - 2026 Year 01 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2026 Year 12 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070035

Disclaimer: Curated by HT Syndication.