A survey of effect of iron supplementation(ferrous sulfate) versus placebo on attention-deficit/hyperactivity disorder symptoms in children under Methylphenidate treatment
This double blinded randomized clinical trial study, with control and parallel groups, will be done on 50 patients with attention-deficit/hyperactivity disorder during 12 weeks. Diagnosis is based on clinical criteria of DSM-IV TR. Three ml of blood sample from children will be taken after obtaining parent informed written contest, and those patients who do not have anemia and their blood ferritin level are lower than 30 ng/ml, will be included in study. Children randomly will be divided into two groups of 25 patients, after screening. Responsiveness to methylphenidate medication will be evaluated and compared by Conners' parent questionnaire in two groups after 12 weeks usage of iron supplementation (ferrous sulfate 80 mg tablets) and placebo. Conners' questionnaire will be filled by parent in first, sixth, and twelfth weeks and severity of symptoms will be analyzed and compared with statistical tests in two groups of iron supplementation and placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212012269N2
Registration date:2013-04-21, 1392/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Elham Bidabadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1772 2901
Email address
mashoof@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of effect of iron supplementation(ferrous sulfate) versus placebo on attention-deficit/hyperactivity disorder symptoms in children under Methylphenidate treatment
Public title
Effect of ferrous sulfate on attention-deficit/hyperactivity disorder symptoms in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Children with attention-deficit/hyperactivity disorder based on DSM-IV TR and under Methylphenidate treatment
2. Lack of anemia (Hemoglobin lower than 11 g/dl)
3. Blood ferritin level lower than 30 ng/ml
Exclusion criteria:
1. Comorbidity of attention-deficit/hyperactivity disorder with other psychiatric disorders
2. Serious and chronic medical disorders (such as malnutrition)
3. Mental retardation
4. Recent inflammation or infection
5. Use of psychopharmacological medications
6. Iron supplementation consumption during recent 3 months, or contraindication for use it.
7.Severe fever (because of pseudo increase in ferritin level)
8.Hypothyroidism (because of pseudo decrease in ferritin level)
Age
From 4 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Type of randomization: Blocked randomization
The study medications (Ferrous sulfate and placebo tablets) will be indistinguishable in terms of appearance, weight and taste.
The investigators together with the participants (children and their parents) will be blinded to the randomization lists until the end of the trial.
"Double blind" will be used as a stringent way of study, to eliminate of unrecognized biases, and to achieve a higher scientific standard than “blind” or “non-blind" experiments.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, West Shahid Beheshti Blvd.
City
Rasht
Postal code
4193893345
Approval date
2012-10-23, 1391/08/02
Ethics committee reference number
1910231203
Health conditions studied
1
Description of health condition studied
Attention deficit/hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together
Primary outcomes
1
Description
Ferritin
Timepoint
Before intervention, 3 months later
Method of measurement
Blood sampling, monobind kit, ELISA method
2
Description
Hemoglobin
Timepoint
Before intervention, 3 months later
Method of measurement
Blood sampling, immunometric method with autoanalyzer