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Zinc-Fortified Wheat Flour + Elementary School Children + Iran + Double-Blind Randomized Clinical Trial

Impact Assessment of Zinc-Fortified Wheat Flour on Zinc Status Among Elementary School Children in Mashhad City: A Double-Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260506069278N1
Enrollment
124
Registered
2026-05-08
Start date
2026-09-22
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Zinc Deficiency in children.

Interventions

Intervention 1: Intervention group: Daily intake of flavored bread made with zinc-fortified wheat flour (and iron and folic acid), along with single-serving packaged milk for 3 months (5 days/weak). I

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 9 Years

Inclusion criteria

Inclusion criteria: A 7 or 8 year old child who is studying in the first and second grade of primary school. Completion of the consent form by the legal guardian and the child At least one of the parents must be literate Not receiving zinc supplements in the last three months and currently. Not taking medications that interfere with zinc absorption or long-term/short-term use of certain medications such as hormonal drugs (growth hormone) and not following special or restricted diets such as vegetarianism Not taking any nutritional supplements in the last three months and/or currently, especially zinc, iron, calcium supplements. The absence of any physical defect or disability that would prevent the child from being able to measure their weight and height. The absence of any disease (and/or condition) and illness in the child.

Exclusion criteria

Exclusion criteria: Unwillingness to continue cooperation in the project Failure to complete the study outcomes at the end of the project, such as biochemical factors The occurrence of any allergy or intolerance to the product in the child Absence from school for any reason that leads to not receiving the product for more than 14 days Any illness during the study that causes the child to receive antibiotics (with any spectrum, amount and type) and penicillin The occurrence of any special medical conditions during the study, such as complications from blood collection

Design outcomes

Primary

MeasureTime frame
Serum zinc. Timepoint: before and at the end. Method of measurement: a lab kit to measure serum zinc.

Secondary

MeasureTime frame
Plasma fatty acid levels to assess the activity of fatty acid elongase and desaturase enzymes. Timepoint: before & after. Method of measurement: Lab.;Urinary Zinc. Timepoint: before, after, one-month follow up. Method of measurement: Lab.;Height and Weight. Timepoint: before, mid and at the end. Method of measurement: Standard Method.;Other Biochemical Tests. Timepoint: Before & After. Method of measurement: Lab.;Appetite and academic progress status, eating behaviour and food record. Timepoint: before, after. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanie Barghchi

Mashhad University of Medical Sciences

haniehbarghchi@gmail.com+98 51 3800 2423

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026