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Efficacy of vitamin D supplementation in children with attention deficit hyperactivity disorder

Phase 3
Conditions
attention deficit hyperactivity disorder.
Disturbance of activity and attention
Registration Number
IRCT201404222394N10
Lead Sponsor
Vice Chancellor for Research, Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Signed parental (mother/father) informed consent; 6-12 years old children; Newly diagnosed attention deficit hyperactivity disorder children by child and adolescent psychiatrist; BMI percentile between 5 to 85. Exclusion criteria: History or current diagnosis of other psychiatric diseases (e.g., autism, bipolar disorder, major depression disorder, etc.) by psychiatrist; History or current diagnosis of neurological condition (e.g., epilepsy, brain tumors, etc.) by psychiatrist; History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.); History of major head trauma ; Diagnosis of Mental retardation; Any medicine administration at least 4weeks before the initiation of the study; Any vitamin D products (enriched products with vitamin D) at least 3 months before the initiation of the study; Any supplement use containing antioxidants like multivitamin, vitamin A,C,E at least 2 months before the initiation of the study.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Symptoms of disease. Timepoint: week 0,4 and 8. Method of measurement: Parental Conners questionnaire.
Secondary Outcome Measures
NameTimeMethod
Symptoms in morning and evening. Timepoint: week 0,4 , 8. Method of measurement: Morning-evening symptoms questionnaire.;Adverse drug effects. Timepoint: week 4,8. Method of measurement: Adverse drug effects questionnaire.;Serum level of Malondialdehyde. Timepoint: week 0,8. Method of measurement: blood test.;Serum level of 8-hydroxydeoxyguanosine. Timepoint: week 0,8. Method of measurement: blood test.;Serum level of 25-hydroxyD. Timepoint: week 0,8. Method of measurement: blood test.
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