Constitutional Growth DelayPhase 2NCT00139451
Nutrients and Hormones: Effects in Boys With Disordered Growth
A Phase 2 study testing Pediasure and GH in people with Constitutional Growth Delay and Nutrition Disorders, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those… Read more about this study
- Who is it for?
- Ages 7 to 10 years, men only
- Conditions the study is for
- Constitutional Growth Delay, Nutrition Disorders, Growth Disorders
- What is being tested?
- Pediasure and GH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2010
- Phase
- Phase 2
- 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 7 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
- Delay in skeletal maturation > 1 year.
Who cannot join
- Growth hormone deficiency
- Chronic illness
- Participation in high endurance athletics
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.
Read the detailed description
Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.
- Being tested
- Pediasure, GH
- Keywords
- GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature
- Medical subject headings
- Puberty, Delayed, Nutrition Disorders, Growth Disorders, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PediasureDrug
With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.
GHDrug
Growth Hormone will be 0.3mg/kg/week, given SC once daily.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Growth Hormone | Active comparator | Not described Receives: Drug: Pediasure; Drug: GH |
| Observation and Growth Hormone | Active comparator | Not described Receives: Drug: GH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height, weight, and body composition
Measured: 6month, 12month, 18month
Secondary outcomes (1)
Changes in total energy expenditure
Measured: 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionDec 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constitutional Growth DelayStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Nelly Mauras, Nemours Children's Clinic
- Investigators
- Nelly Mauras, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139451
- Sponsor's protocol ID
- IRB # 04-016
- Status last verified
- Oct 2011
- First submitted
- 29 Aug 2005
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrients and Hormones: Effects in Boys With Disordered Growth
- ClinicalTrials.gov ID
- NCT00139451
- Acronym / sponsor ID
- IRB # 04-016
- Keywords
- GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 31 Aug 2005 (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.
The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.
Detailed description
Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Growth Hormone | Active comparator | Drug: Pediasure, Drug: GH |
| Observation and Growth Hormone | Active comparator | Drug: GH |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
- Delay in skeletal maturation > 1 year.
Key exclusion criteria (3 listed)
- Growth hormone deficiency
- Chronic illness
- Participation in high endurance athletics
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 |
|---|---|---|
| PediasureWith the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo. | Drug | Nutrition and Growth Hormone |
| GHGrowth Hormone will be 0.3mg/kg/week, given SC once daily. | Drug | Nutrition and Growth Hormone, Observation and Growth Hormone |
Primary outcome
Change in height, weight, and body composition
Time frame: 6month, 12month, 18month
1 secondary outcome
Changes in total energy expenditure
Time frame: 6month, 12month
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 12 Oct 2011.
- issues related to child healthLink provided by the sponsor.
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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.
Nelly Mauras, MD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pediasure and GH in people with Constitutional Growth Delay and Nutrition Disorders, run by Nemours Children's Clinic at 1 site in United States.
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 2 inclusion and 3 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 12 Oct 2011. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in height, weight, and body composition (time frame: 6month, 12month, 18month). 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 12 Oct 2011.