Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139451
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2005-08-29
Brief Title:
Nutrients and Hormones Effects in Boys With Disordered Growth
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Nutrients and Hormones Effects in Boys With Disordered Growth
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None