Effect of ferrous sulfate on attention-deficit/hyperactivity disorder symptoms in children

A survey of effect of iron supplementation(ferrous sulfate) versus placebo on attention-deficit/hyperactivity disorder symptoms in children under Methylphenidate treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201212012269N2

Enrollment

Registered

2013-04-21

Start date

2012-12-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Attention deficit/hyperactivity disorder. A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together

Interventions

Intervention 1: Ferrous sulfate (brand name: Ferrous sulfate), 80 mg oral tablet, manufactured by Shahre Daru Co., daily for 3 months. Intervention 2: Placebo, oral tablet, manufactured by Shahre Daru

Treatment - Drugs

Ferrous sulfate (brand name: Ferrous sulfate), 80 mg oral tablet, manufactured by Shahre Daru Co., daily for 3 months

Placebo, oral tablet, manufactured by Shahre Daru Co., contains: Lactose- Avicel- Polyvinylpyrrolidone (PVP), daily for 3 months

Eligibility

Sex/Gender

All

Age

4 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Children with attention-deficit/hyperactivity disorder based on DSM-IV TR and under Methylphenidate treatment 2. Lack of anemia (Hemoglobin lower than 11 g/dl) 3. Blood ferritin level lower than 30 ng/ml Exclusion criteria: 1. Comorbidity of attention-deficit/hyperactivity disorder with other psychiatric disorders 2. Serious and chronic medical disorders (such as malnutrition) 3. Mental retardation 4. Recent inflammation or infection 5. Use of psychopharmacological medications 6. Iron supplementation consumption during recent 3 months, or contraindication for use it. 7.Severe fever (because of pseudo increase in ferritin level) 8.Hypothyroidism (because of pseudo decrease in ferritin level)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Ferritin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, monobind kit, ELISA method.;Hemoglobin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, immunometric method with autoanalyzer.;TIBC. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method.;Iron. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method.	—

Measure

Time frame

Ferritin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, monobind kit, ELISA method.;Hemoglobin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, immunometric method with autoanalyzer.;TIBC. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method.;Iron. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method.

—

Secondary

Measure	Time frame
Attention Deficit Hyperactivity Disorder (ADHD) index. Timepoint: First, Sixth, and twelfth weeks. Method of measurement: Conners' Parent Rating Scale (CPRS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Esmaili Gurabi

Guilan University of Medical Sciences

esmaili.hamed@yahoo.com+98 13 1669 0099

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026