Growth Hormone DeficiencyNCT02973061
The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
An observational study of Growth Hormone Deficiency and Attention Deficit Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit and hyperactivity charachteristics in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales)… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency, Attention Deficit Disorder, Idiopathic Short Stature
- What is being tested?
- Questionnaires
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children ages 6-16 years receiving recombinant growth hormone will be compared to those untereated
Who may be able to join
- Children over the age of 6 years, and less than 16 years
- Children eligible for rhGH treatment according to the following Food and Drug Administration approved indications; Small for gesational age, Idioapathic short stature, GH deficiency and chronic renal failure.
- Consent of parents / guardian to participate in research
Who cannot join
- - Under the age of 6 years and above 16 years
- Previously diagnosed with neurocognitive disease
- Previously diagnosed with specific syndromes: Prader-willi syndrome, Turner
- Previously diagnosed with Attention Deficit/Hyperactivity disorder
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Haroffeh Medical center
Zrifin, 70300
Marianna Rachmiel, md, 972-8-9542007, mariannar@asaf.health.gov.il
About this study
Official title: The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents
Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit and hyperactivity charachteristics in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD.
Data will be compared to healthy control group.
Read the detailed description
Background The main objective of this study is to analyze the short-and long-term influence of recombinant growth hormone on clinical and questionnaires based criteria of attention deficit/hyperactivity disorder in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD. All participants will be treated by rhGH doses acceptable by the FDA recommendations.
Trial Goal The main goal of this trial is to assess if there is any association between treatment with rhGH during a short period of 3 months, or a long period of 3-12 months and the development of characteristics of ADHD (measurable parameters )
Hypothesis Our research hypothesis, is that although parents fear of hyperreactive symptoms after rGH administration, our study will demonstrate that providing regular management of recombinant human growth hormone therapy over time, will not be associated with significant change in attention deficit/hyperactive characteristics compared to matched age and sex controls who did not receive GH treatment. This prospective case control study format study has been chosen in order to observe and document any behavioural influence with the recommended and standard treatment with GH treatment given according to current guidelines.
Study population and size were decided according to a statistician calculation of 80% power and 5% significance and with a consiideration of 15% drop-out
Trial design An open prospective observational case control study that will recruit children and adolescents prior to initiation of GH treatment. This is a single-site study, however patients who comply with inclusion and exclusion criteria, may be recruited by the media, by representatives of pharmaceutical companies, medical associations and the Children's Endocrinology Association. Every eligible participant, wherever treated for his condition may take part in the study.
The study design is to compare, in a controlled case-control manner, prospectively. The development of ADHD characteristics in a group of patients from initiation to 12 months of treatment with rhGH compared to a similar gender and age controlled group, not treated by rhGH.
Statistical Analysis All data will be presented in mean ,min and max. The data will be divided according to age and results.
Statistical analysis will be performed by ANOVA with repeated measures, which will examine the difference between the trial and control group, at the 4 different time points, as well as the difference in each patient for itself, the influence of time and the interaction between these measures.
- Being tested
- Questionnaires
- Medical subject headings
- Dwarfism, Pituitary, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
All participants families will fulfill a periodic questionnaire regarding attention, behaviour.
| Study group | Role | What they receive |
|---|---|---|
| GH treated patients | All participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months Receives: Other: Questionnaires | |
| Healthy control | All participants family member and teacher will fill questionnaires regarding signs of atention deficit at baseline and after 6 and 12 months Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD criteria
questionnaires analysis will give a definite number. Criteria will be compared between groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- marianna Rachmiel, md, Principal investigator, Assaf Haroffeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973061
- Sponsor's protocol ID
- 240/14
- Status last verified
- Aug 2022
- First submitted
- 22 Nov 2016
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02973061
- Acronym / sponsor ID
- 240/14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit and hyperactivity charachteristics in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD.
Data will be compared to healthy control group.
Detailed description
Background The main objective of this study is to analyze the short-and long-term influence of recombinant growth hormone on clinical and questionnaires based criteria of attention deficit/hyperactivity disorder in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD. All participants will be treated by rhGH doses acceptable by the FDA recommendations.
Trial Goal The main goal of this trial is to assess if there is any association between treatment with rhGH during a short period of 3 months, or a long period of 3-12 months and the development of characteristics of ADHD (measurable parameters )
Hypothesis Our research hypothesis, is that although parents fear of hyperreactive symptoms after rGH administration, our study will demonstrate that providing regular management of recombinant human growth hormone therapy over time, will not be associated with significant change in attention deficit/hyperactive characteristics compared to matched age and sex controls who did not receive GH treatment. This prospective case control study format study has been chosen in order to observe and document any behavioural influence with the recommended and standard treatment with GH treatment given according to current guidelines.
Study population and size were decided according to a statistician calculation of 80% power and 5% significance and with a consiideration of 15% drop-out
Trial design An open prospective observational case control study that will recruit children and adolescents prior to initiation of GH treatment. This is a single-site study, however patients who comply with inclusion and exclusion criteria, may be recruited by the media, by representatives of pharmaceutical companies, medical associations and the Children's Endocrinology Association. Every eligible participant, wherever treated for his condition may take part in the study.
The study design is to compare, in a controlled case-control manner, prospectively. The development of ADHD characteristics in a group of patients from initiation to 12 months of treatment with rhGH compared to a similar gender and age controlled group, not treated by rhGH.
Statistical Analysis All data will be presented in mean ,min and max. The data will be divided according to age and results.
Statistical analysis will be performed by ANOVA with repeated measures, which will examine the difference between the trial and control group, at the 4 different time points, as well as the difference in each patient for itself, the influence of time and the interaction between these measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH treated patients | – | Other: QuestionnairesAll participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months |
| Healthy control | – | Other: QuestionnairesAll participants family member and teacher will fill questionnaires regarding signs of atention deficit at baseline and after 6 and 12 months |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children ages 6-16 years receiving recombinant growth hormone will be compared to those untereated
Key inclusion criteria (3 listed)
- Children over the age of 6 years, and less than 16 years
- Children eligible for rhGH treatment according to the following Food and Drug Administration approved indications; Small for gesational age, Idioapathic short stature, GH deficiency and chronic renal failure.
- Consent of parents / guardian to participate in research
Key exclusion criteria (4 listed)
- - Under the age of 6 years and above 16 years
- Previously diagnosed with neurocognitive disease
- Previously diagnosed with specific syndromes: Prader-willi syndrome, Turner
- Previously diagnosed with Attention Deficit/Hyperactivity disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAll participants families will fulfill a periodic questionnaire regarding attention, behaviour. | Other | GH treated patients, Healthy control |
Primary outcome
ADHD criteria
Time frame: 12 months
questionnaires analysis will give a definite number. Criteria will be compared between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marianna Rachmiel, md principal investigator
Assaf Haroffeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Attention Deficit Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianna Rachmiel, md (97289542007, mariannar@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.