The effect of vitamin D on the treatment of symptoms in children with attention deficit hyperactivity disorder

Phase 3

Conditions: Attention deficit hyperactivity disorder.
Attention-deficit hyperactivity disorders

Registration Number: IRCT20120314009297N4

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
Without vitamin D deficiency (Serum 25(OH) vitamin D levels above 30ng/ml)
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 relapse
Psychiatric comorbidity as defined by DSM-V
Mental retardation
Neurological diseases such as delirium, seizure, traumatic brain injury
Current significant unstable medical illness
Hypersensitivity to vitamin D
Previous treatment with any products enriched with vitamin D 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

Name	Time	Method
The scores of emotional and behavioral problems in Strengths and Difficulties Questionnaire. Timepoint: At baseline and days 45 and 90 of the baseline. Method of measurement: Strengths and Difficulties Questionnaire (SDQ).;The scores of symptoms of hyperactivity, impulsivity and cognitive impairment of ADHD in Parent's Rutter Questionnaire. Timepoint: At baseline and days 45 and 90 of the baseline. Method of measurement: Parent's Rutter questionnaire.;The scores of symptoms of hyperactivity, impulsivity and cognitive impairment of ADHD in Conners' Parent Rating Scale. Timepoint: At baseline and days 45 and 90 of the baseline. Method of measurement: Conners' Parent Rating Scale.;Serum 25(OH) vitamin D level. Timepoint: At baseline and day 90 from baseline. Method of measurement: ELISA Kit.;Side effects of vitamin D. Timepoint: At baseline and days 45 and 90 of the baseline. Method of measurement: Side effects checklist and Serum 25(OH) vitamin D level.

Secondary Outcome Measures

Name	Time	Method
Weight. Timepoint: At baseline and day 90 from baseline. Method of measurement: Scales.;Waist circumference. Timepoint: At baseline and day 90 from baseline. Method of measurement: Tape.;Body mass index. Timepoint: At baseline and day 90 from baseline. Method of measurement: Using the formula kilograms per square meter of height(Kg/m2).;Serum total cholesterol level. Timepoint: At baseline and day 90 from baseline. Method of measurement: Laboratory kit.;Serum Low-density lipoprotein(LDL) level. Timepoint: At baseline and day 90 from baseline. Method of measurement: Laboratory kit.;Serum High density lipoprotein (HDL) level. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit.;Serum triglyceride level. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit.;Serum fasting blood sugar level. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit.