UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061205 |
|---|---|
| Receipt number | R000070035 |
| Scientific Title | Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 04:07:51 |
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Basic information
Public title
Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls: A Randomized Controlled Trial
Acronym
Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls
Scientific Title
Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls
Scientific Title:Acronym
Effect of Iron-Fortified Wheat Flour on Iron Status, Cognitive Function, Inflammatory and Immune Markers among Adolescent Girls
Region
| Asia(except Japan) |
Condition
Condition
Nil
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Interventions/Control_1
Interventions/Control_2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_3
Interventions/Control_4
Interventions/Control_4
Interventions/Control_5
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | < |
Age-upper limit
| 16 | 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 sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Dr Niamatullah |
| Middle name | |
| Last name | alam |
Organization
Department of Human Nutrition, The University of Agriculture Peshawar, Pakistan
Division name
Department of Human Nutrition, The University of Agriculture Peshawar, Pakistan
Zip code
25000
Address
niamatsami@gmail.com
TEL
00923455104041
niamatullah@aup.edu.pk
Public contact
Name of contact person
| 1st name | iftikhar |
| Middle name | |
| Last name | alam |
Organization
Bacha Khan University Charsadda Pakistan
Division name
HND
Zip code
25000
Address
HND Bacha Khan University Charsadda Pakistan
TEL
00923455104041
Homepage URL
iftikharalam@bkuc.edu.pk
Sponsor or person
Institute
AUP
Institute
Department
Personal name
Funding Source
Organization
AUP
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bacha Khan University Charsadda Pakistan
Address
Bacha Khan University Charsadda Pakistan
Tel
00923455104041
iftikharalam@bkuc.edu.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070035
