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

Study of the efficacy and safety of vitamin D add-on standard treatment regimen for children with attention-deficit hyperactivity disorder in 7- to 14 year-Old : A 12 weeks randomized, open-label, parallel group Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120314009297N4
Enrollment
38
Registered
2018-05-14
Start date
2017-03-21
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

Attention deficit hyperactivity disorder. Attention-deficit hyperactivity disorders

Interventions

Intervention 1: Intervention group: receive vitamin A+D drop with a dose of 400 unit/day for vitamin D for 12 weeks along with their standard therapeutic regimen. Intervention 2: Control group: recei

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 14 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Hendouei

Mazandaran University of Medical Sciences

hendoieen@yahoo.com+98 11 3354 2472

Outcome results

None listed

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