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The effect of ferrous sulphate on the treatment of symptoms in children with attention deficit hyperactivity disorder

Phase 3
Conditions
Attention deficit hyperactivity disorder.
Attention-deficit hyperactivity disorder, combined type
Registration Number
IRCT20120314009297N3
Lead Sponsor
Mazandaran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
38
Inclusion Criteria

7-14 years old children
Diagnosed attention deficit hyperactivity disorder children by two psychiatrists and based on DSM-V and without iron deficiency and anemia (Serum ferritin above 15 µg /L and serum hemoglobin equal to or greater than 11 g /dl )
All patients are on standard treatment regimen for attention-deficit hyperactivity disorder for at least 3 months and a stable dose for at least 1 month.

Exclusion Criteria

Acute phase of the disease
Psychiatric comorbidity as defined by DSM-V (bipolar disorder, Major depressive disorder)
Mental retardation
Neurological diseases such as delirium, seizure, traumatic brain injury
Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
Hypersensitivity to iron sulphate
Previous treatment with any enriched medical products with iron at least 2 months before the initiation
Unwillingness of the patient or his guardian to participate in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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