Short StatureNCT00562705
Effects of Growth Hormone (GH) Treatment on Eating Regulation
A study testing growth hormone- Genotropin or NorditropinSimplex and nutritional intervention and growth hormone-Genotropin or NorditropinSimplex or "Biotropin" in people with Short Stature, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Short Stature
- What is being tested?
- growth hormone- Genotropin or NorditropinSimplex and nutritional intervention and growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Aug 2012
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Height of at least 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
- Children that have one of the following short stature pathologies:
- IGHD or MPHD
- ISS
- SGA
- Proper function of thyroid gland, kidney and liver
- Prior to initiating growth hormone treatment
Who cannot join
- Chronic diseases
- Diseases in the digestive system.
- Neurological diseases.
- Malignant diseases in the past or in the present. Treated with chemotherapy or radiation.
- Genetic syndromes
- Bone diseases
- Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone signal transduction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment, children will be randomized into two groups:
Read more
- Control group that will continue with growth hormone treatment without any other intervention.
- Study group that will be a given a nutritional intervention in addition to growth hormone treatment.
At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, child eating behavior questionnaire, blood tests, hormonal tests and resting energy expenditure measurements.
Read the detailed description
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
Background:
In the last three decades children with different kinds of short stature pathologies were treated with growth hormone. Most of the attention in growth hormone studies is focused on the effect of the treatment on growth. Today there are very few studies that are focused on the effect of growth hormone on eating regulations and the connection between eating regulations and growth improvement in growth hormone treatment.
Objectives:
- To evaluate the effect of short term growth hormone treatment on the following parameters:
- Appetite, food preference, amount of food and ingredients.
- Changes in food regulations.
- Changes in body composition.
- Changes in resting energy expenditure.
- Changes in hormones that are associated with appetite and with energy balance: IGF-1,IGFBP1\&3 and Ghrelin.
- Changes in metabolic and nutritional measurements: glucose, insulin, lipid profile, total proteins, albumin, liver functions, alkaline-phosphatase, hemoglobin, transferrin, iron, B12, folic acid.
- To evaluate the effect of nutritional support on growth rate in one year growth hormone treatment.
- To evaluate changes in growth markers in the serum and urine during growth hormone treatment.
Methods:
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment children will be randomized into two groups:
- Control group that will continue with growth hormone treatment without any other intervention.
- Study group that will be given a nutritional intervention In addition to growth hormone treatment.
The nutritional intervention will include nutritional consultation and applying a personal dietetic menu. At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, food diary, child eating behavior questionnaire, resting energy expenditure measurements, blood tests, hormonal tests and fasting and post-prandial levels of leptin, ghrelin, GLP-1, insulin and glucose.
- Conditions
- Short Stature
- Being tested
- growth hormone- Genotropin or NorditropinSimplex and nutritional intervention, growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
- Keywords
- growth hormone, eating regulation, nutritional intervention, short stature, ISS, SGA, IGHD, MPHD
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormone- Genotropin or NorditropinSimplex and nutritional interventionBehavioural
A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention
growth hormone-Genotropin or NorditropinSimplex or "Biotropin"Behavioural
Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Growth hormone and nutritional intervention Receives: Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention |
| 2 | Active comparator | growth hormone Receives: Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin" |
What is being measured
The primary outcome is the main question the study is designed to answer.
height and weight
Measured: every visit until the end of study
Growth markers
Measured: At screening visit, baseline and at the end of the visit
Secondary outcomes (3)
Safety laboratory parameters
Measured: at screening, baseline and at the end of the study
food diary
Measured: every visit until the end of the study
Resting energy expenditure measurements
Measured: Every visit other than visit number 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Professor, Principal investigator, Schneider Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562705
- Sponsor's protocol ID
- rmc004623ctil
- Status last verified
- Jul 2013
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children
- ClinicalTrials.gov ID
- NCT00562705
- Acronym / sponsor ID
- rmc004623ctil
- Conditions
- Short Stature
- Keywords
- growth hormone, eating regulation, nutritional intervention, short stature, ISS, SGA, IGHD, MPHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Nov 2007 (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.
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment, children will be randomized into two groups:
- Control group that will continue with growth hormone treatment without any other intervention.
- Study group that will be a given a nutritional intervention in addition to growth hormone treatment.
At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, child eating behavior questionnaire, blood tests, hormonal tests and resting energy expenditure measurements.
Detailed description
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
Background:
In the last three decades children with different kinds of short stature pathologies were treated with growth hormone. Most of the attention in growth hormone studies is focused on the effect of the treatment on growth. Today there are very few studies that are focused on the effect of growth hormone on eating regulations and the connection between eating regulations and growth improvement in growth hormone treatment.
Objectives:
- To evaluate the effect of short term growth hormone treatment on the following parameters:
- Appetite, food preference, amount of food and ingredients.
- Changes in food regulations.
- Changes in body composition.
- Changes in resting energy expenditure.
- Changes in hormones that are associated with appetite and with energy balance: IGF-1,IGFBP1\&3 and Ghrelin.
- Changes in metabolic and nutritional measurements: glucose, insulin, lipid profile, total proteins, albumin, liver functions, alkaline-phosphatase, hemoglobin, transferrin, iron, B12, folic acid.
- To evaluate the effect of nutritional support on growth rate in one year growth hormone treatment.
- To evaluate changes in growth markers in the serum and urine during growth hormone treatment.
Methods:
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment children will be randomized into two groups:
- Control group that will continue with growth hormone treatment without any other intervention.
- Study group that will be given a nutritional intervention In addition to growth hormone treatment.
The nutritional intervention will include nutritional consultation and applying a personal dietetic menu. At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, food diary, child eating behavior questionnaire, resting energy expenditure measurements, blood tests, hormonal tests and fasting and post-prandial levels of leptin, ghrelin, GLP-1, insulin and glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional interventionGrowth hormone and nutritional intervention |
| 2 | Active comparator | Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"growth hormone |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Height of at least 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
- Children that have one of the following short stature pathologies:
- Proper function of thyroid gland, kidney and liver
- Prior to initiating growth hormone treatment
Key exclusion criteria (7 listed)
- Chronic diseases
- Diseases in the digestive system.
- Neurological diseases.
- Malignant diseases in the past or in the present. Treated with chemotherapy or radiation.
- Genetic syndromes
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 |
|---|---|---|
| growth hormone- Genotropin or NorditropinSimplex and nutritional interventionA combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention | Behavioural | 1 |
| growth hormone-Genotropin or NorditropinSimplex or "Biotropin"Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin"). | Behavioural | 2 |
Primary outcome
height and weight
Time frame: every visit until the end of study
Growth markers
Time frame: At screening visit, baseline and at the end of the visit
3 secondary outcomes
Safety laboratory parameters
Time frame: at screening, baseline and at the end of the study
food diary
Time frame: every visit until the end of the study
Resting energy expenditure measurements
Time frame: Every visit other than visit number 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
Related trials for Short Stature
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
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
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.
Moshe Phillip, Professor principal investigator
Schneider Children Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing growth hormone- Genotropin or NorditropinSimplex and nutritional intervention and growth hormone-Genotropin or NorditropinSimplex or "Biotropin" in people with Short Stature, run by Rabin 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jul 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height and weight (time frame: every visit until the end of study). The study lists 2 primary outcomes in all. 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 16 Jul 2013.