Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls: A Randomized Controlled Trial

Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls - Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061205

Enrollment

250

Registered

2026-04-09

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nil

Interventions

Interventions/Control_1 Interventions/Control_2 Interventions/Control_3 Interventions/Control_4 Interventions/Control_5

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Hemoglobin concentration (g/dL) Measured using an automated hematology analyzer. Blood samples collected at baseline and post-intervention (12 weeks). Hemoglobin reflects anemia status and overall iron status (Gera et al., 2020; Suchdev et al., 2020). Serum ferritin (ug/L) Measured using ELISA or immunoassay. Indicates iron storage in the body. Adjusted for inflammation using CRP levels (Suchdev et al., 2020; Righetti et al., 2020). Serum iron (ug/dL) Assessed by atomic absorption spectrophotometry or immunoassay. Reflects circulating iron available for erythropoiesis. Transferrin saturation (%) Calculated from serum iron and total iron-binding capacity. Indicates proportion of transferrin bound to iron (Zimmermann et al., 2021). Timepoints: Baseline and post-intervention (12 weeks)	—

Measure

Time frame

Hemoglobin concentration (g/dL) Measured using an automated hematology analyzer. Blood samples collected at baseline and post-intervention (12 weeks). Hemoglobin reflects anemia status and overall iron status (Gera et al., 2020; Suchdev et al., 2020). Serum ferritin (ug/L) Measured using ELISA or immunoassay. Indicates iron storage in the body. Adjusted for inflammation using CRP levels (Suchdev et al., 2020; Righetti et al., 2020). Serum iron (ug/dL) Assessed by atomic absorption spectrophotometry or immunoassay. Reflects circulating iron available for erythropoiesis. Transferrin saturation (%) Calculated from serum iron and total iron-binding capacity. Indicates proportion of transferrin bound to iron (Zimmermann et al., 2021). Timepoints: Baseline and post-intervention (12 weeks)

—

Countries

Asia(except Japan)

Contacts

Public Contactiftikhar alam

Bacha Khan University Charsadda Pakistan HND

iftikharalam@bkuc.edu.pk00923455104041

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026