Efficacy and safety of ferrous sulphate add-on standard treatment regimen for children with attention-deficit hyperactivity disorder in 7- to 14 year-Old without iron deficiency and anemia : A 12 weeks randomized, open-label, parallel group Study
Evaluation of the efficacy and safety of ferrous sulphate add-on standard treatment regimen for children with attention-deficit hyperactivity disorder(ADHD) and without iron deficiency and anemia in 7- to 14 year-Old On the ADHD symptoms and growth status
Design
A randomized, open-label, controlled clinical trial, design of 38 patients with ADHD(1: 1 in each group), between March and October 2017
Settings and conduct
Pediatric Psychiatric Clinic of Zare Hospital affiliated to Mazandaran University of Medical Sciences, Sari, Iran
Pediatric Psychiatric Clinic of Roozbeh hospital affiliated to Tehran University of Medical Sciences, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: 7-14 years old children with ADHD and without iron deficiency and anemia
Exclusion criteria: acute phase of the disease; underlying disease; mental retardation; Previous treatment with any enriched products with iron at least 2 months before the initiation
Intervention groups
Subjects in the intervention group receive ferrous sulphate tablet with a dose of 1 mg / kg according to elemental iron with standard therapeutic regimen and the control group receive standard therapeutic regimen alone for 12 weeks
Main outcome variables
Strengths and Difficulties Questionnaire for assessment of emotional and behavioral problems; Rutter and Conners' Parent Rating Scale for assessment of the improvement of the ADHD symptoms were used at the baseline and on the 45th and 90th days. Serum iron; ferritin; Hemoglobin ; Hematocrit; Total iron-binding capacity (TIBC) ; Height; weight; waist; body mass index; serum cholesterol profiles; fasting blood sugar were measured at the baseline and on the 90th day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120314009297N3
Registration date:2018-04-30, 1397/02/10
Registration timing:retrospective
Last update:2018-04-30, 1397/02/10
Update count:0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
narjes hendouei
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 911 327 0107
Email address
hendoieen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
Efficacy and safety of ferrous sulphate add-on standard treatment regimen for children with attention-deficit hyperactivity disorder in 7- to 14 year-Old without iron deficiency and anemia : A 12 weeks randomized, open-label, parallel group Study
Public title
The effect of ferrous sulphate on the treatment of symptoms in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 7 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers and 1: 1 ratio in treatment group and control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem street, Moallem square, Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.MAZUMS.REC.1396.2832
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Emotional and behavioral problems
Timepoint
At the baseline and on the 45th and 90th days
Method of measurement
Strengths and Difficulties Questionnaire (SDQ)
2
Description
Severity of symptoms in hyperactivity, impulsivity and cognitive impairment in children with ADHD
Timepoint
At the baseline and on the 45th and 90th days
Method of measurement
Rutter Behavioral Disorder Questionnaire
3
Description
Severity of symptoms in hyperactivity, impulsivity and cognitive impairment in children with ADHD
Timepoint
At the baseline and on the 45th and 90th days
Method of measurement
Conners' Parent Rating Scale
4
Description
Serum iron level
Timepoint
At the baseline and on the 90th day
Method of measurement
ELISA Kit
5
Description
Serum ferritin level
Timepoint
At the baseline and on the 90th day
Method of measurement
ELISA Kit
6
Description
Hemoglobin; Hematocrit
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory data
7
Description
Total iron-binding capacity (TIBC)
Timepoint
At the baseline and on the 90th day
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Height
Timepoint
At the baseline and on the 90th day
Method of measurement
Height gauge
2
Description
Weight
Timepoint
At the baseline and on the 90th day
Method of measurement
Scales
3
Description
Waist circumference
Timepoint
At the baseline and on the 90th day
Method of measurement
Tape
4
Description
Body mass index
Timepoint
At the baseline and on the 90th day
Method of measurement
Using the formula kilograms per square meter of height(Kg/m2)
5
Description
Serum total cholesterol level
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory kit
6
Description
Low-density lipoprotein(LDL)
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory kit
7
Description
High density lipoprotein (HDL)
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory kit
8
Description
Serum triglyceride level
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory kit
9
Description
Fasting blood sugar
Timepoint
At the baseline and on the 90th day
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: receive ferrous sulphate tablet with a dose of 1 mg / kg according to elemental iron for 12 weeks along with their standard therapeutic regimen
Category
Treatment - Drugs
2
Description
Control group: receive their standard therapeutic regimen alone for 12 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Psychiatric Clinic of Zare Hospital
Full name of responsible person
Narjes Hendouei
Street address
Zare Hospital, Taravat St., Neka Road
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
2
Recruitment center
Name of recruitment center
Pediatric Psychiatric Clinic of Roozbeh hospital
Full name of responsible person
Samaneh Farnia
Street address
Roozbeh hospital, District 11, Karegar St, No. 606
City
Tehran
Province
Tehran
Postal code
443256987
Phone
+98 21 8896 6921
Email
sm.farnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem street, Moallem square-Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3326 1245
Email
tmaae@liv.ac.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have not decided yet - its release plan is still unclear