Study Group II
By Ami Ballin, MD
Gender Medicine is not familiar to most pediatricians. Gender differences are not the focus in most of the studies in pediatrics. Response to treatment and side effects of medications may emphasize gender differences. Adolescents may serve as an appropriate population for this scope.
Aim of the study
The purpose of this study is to find out if there are side effects (mainly with regards to growth and weight) to methylphenidate (M) therapy in adolescents. Moreover, this study aims to investigate if there are side effects, are they similar or different between males and females?
The introduction of sex hormones to the process of growth in adolescents adds to the social and cultural differences between the genders regarding the effects of M therapy. Studies that have been done with animals have presented conflicting data regarding the effect of M on sex hormones.
General Study Overview
- This prospective study will include adolescent males and females age 12 to 18 who receive M therapy on a daily basis. These patients will have started to take this medication at least 3 months before the initiation of the study.
- The control group will consist of healthy males and female adolescents, age 12 to 18, , who do not take M or any other medications.
- Exclusion criteria:
a) Any chronic disease (apart from ADHD)
b) Anemia of more than 6 months
c) Low compliance already familiar to the pediatrician
d) Chronic consumption of any drug
- This study will start on 1.6.2015 and last for 9 months (until 30.3.2016).
- In the first month, the following patient data will be recorded: name (initials), age, sex, number of months he/she has been on therapy, height, weight, MI, name of medication and daily dosage per kg.
- During the final month of the study, (March 2016) the height, weight and BMI will be recorded again (measured in the same place as in the first time), as well as the daily dosage per kg.
- All participants of the study group will be asked to fill out a questionnaire about any side effects that they attribute to M therapy.
- The differences between the three parameters (height, weight and BMI), will be recorded in relation to the age and gender of the participants within the two groups.
- Since this study will be anonymous, parental consent will not be needed.
- This is a simple, basic, “skeletal protocol.” In the event that financial support is given to the study, one may add to it some laboratory parameters like sex hormones.
- The first step will be to get an approval from the Ethics Committee.
- The results of the study will be collected and presented at the 2016 CoPedia meeting (in Barcelona). A manuscript will be composed and stand for publication. All participants will be shown in the list of authors.
We have to pleasure to invite to join this study group.
Please send an e-mail directly to Prof. Ballin advising him that you would like to take part in the research