|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00562705 |
|
Date of registration:
|
21/11/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Growth Hormone (GH) Treatment on Eating Regulation
|
|
Scientific title:
|
Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children |
|
Date of first enrolment:
|
January 2008 |
|
Target sample size:
|
32 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00562705 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Moshe Phillip, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Schneider Children Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. 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).
2. Children that have one of the following short stature pathologies:
1. IGHD or MPHD
2. ISS
3. SGA
3. Proper function of thyroid gland, kidney and liver
4. Prior to initiating growth hormone treatment
Exclusion Criteria:
1. Chronic diseases
2. Diseases in the digestive system.
3. Neurological diseases.
4. Malignant diseases in the past or in the present. Treated with chemotherapy or
radiation.
5. Genetic syndromes
6. Bone diseases
7. Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone
signal transduction.
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Short Stature
|
|
Intervention(s)
|
|
Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
|
|
Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
|
|
Primary Outcome(s)
|
|
Growth markers
[Time Frame: At screening visit, baseline and at the end of the visit]
|
|
height and weight
[Time Frame: every visit until the end of study]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
rmc004623ctil
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|