Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102258
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-01-25
Brief Title:
Role of Nutrition and Hormones in Boys With Disordered Growth
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nutrients and Hormones Effects in Boys With Disordered Growth - Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-10-02
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:
This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin a growth hormone that is used to help children grow taller The Food and Drug Administration has approved Nutropin for use in children who are very short This study will examine whether giving nutritional supplements in addition to Nutropin can help children grow better than with Nutropin alone
Boys between 7 and 10 years of age who are very short and below average in weight but are otherwise healthy may be eligible for this study Candidates must qualify for Nutropin treatments to boost their growth Boys will be recruited for the study from the Nemours Childrens Clinic in Jacksonville FL and from the National Institutes of Health in Bethesda MD
Participants are randomly assigned to one of two treatment groups One group is observed for 6 months and then receives a Nutropin injection every day for 12 months The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months In addition to treatment participants undergo the following tests and procedures at the schedule indicated Baseline 3 6 9 12 15 and 18 months
Clinical examination
Height measurement
Body composition assessment Skin-fold thickness calipers are used in four places on the body to estimate body fat
Bioelectric impedance A small amount of electrical current is used to calculate the percentage of body fat
Baseline 6 12 and 18 months
Blood tests
Bone age x-ray x-ray of the left hand to measure growth potential
DEXA dual energy x-ray absorptiometry scan x-ray scan to measure body fat muscle and bone mineral content The subject lies on a flat table during the scan
Baseline 6 and 12 months
Record of dietary intake Parents are asked to write down everything the child eats and drinks for 3 days Using this record a dietitian calculates the daily caloric intake
Total energy expenditure This test determines how much energy the child uses For the test the child drinks water labeled with harmless isotopes heavy oxygen and heavy hydrogen For the next 10 days he collects urine in plastic tubes at home At the end of the 10 days the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body This information is used to calculate how much energy the child expends each day
Participants weight is measured at 2 and 4 weeks and then monthly for the remainder of the 18-month study
Boys between 7 and 10 years of age who are very short and below average in weight but are otherwise healthy may be eligible for this study Candidates must qualify for Nutropin treatments to boost their growth Boys will be recruited for the study from the Nemours Childrens Clinic in Jacksonville FL and from the National Institutes of Health in Bethesda MD
Participants are randomly assigned to one of two treatment groups One group is observed for 6 months and then receives a Nutropin injection every day for 12 months The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months In addition to treatment participants undergo the following tests and procedures at the schedule indicated Baseline 3 6 9 12 15 and 18 months
Clinical examination
Height measurement
Body composition assessment Skin-fold thickness calipers are used in four places on the body to estimate body fat
Bioelectric impedance A small amount of electrical current is used to calculate the percentage of body fat
Baseline 6 12 and 18 months
Blood tests
Bone age x-ray x-ray of the left hand to measure growth potential
DEXA dual energy x-ray absorptiometry scan x-ray scan to measure body fat muscle and bone mineral content The subject lies on a flat table during the scan
Baseline 6 and 12 months
Record of dietary intake Parents are asked to write down everything the child eats and drinks for 3 days Using this record a dietitian calculates the daily caloric intake
Total energy expenditure This test determines how much energy the child uses For the test the child drinks water labeled with harmless isotopes heavy oxygen and heavy hydrogen For the next 10 days he collects urine in plastic tubes at home At the end of the 10 days the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body This information is used to calculate how much energy the child expends each day
Participants weight is measured at 2 and 4 weeks and then monthly for the remainder of the 18-month study
Detailed Description:
We propose a pilot study to examine the role of nutrition and its interaction with growth hormone GH therapy in boys with very short stature who also have delayed bone age characteristic of constitutional delay of growth and maturation CDGM Recent studies have suggested that insufficient caloric intake may contribute to the pathophysiology of CDGM This prompted us to consider whether nutritional intervention may benefit children with severe short stature who also have CDGM
To investigate this further we would like to enroll a total of 20 boys 10-15 boys in Jacksonville Florida and 5-10 boys at the NIH Bethesda Maryland ages 7-10 years who are otherwise healthy but have significant short stature height SDS less than -225 the current FDA approved indication for the use of GH in idiopathic short stature delayed bone age greater than 12 months below chronologic age and low BMI and weight-for-height less than 25th percentile Ten boys will be randomized to receive observation for 6 months followed by GH therapy for 12 months Ten boys will be randomized to receive daily liquid nutritional supplementation for 6 months followed by combined GH therapy and nutritional supplementation for 12 months For all subjects weight gain will be monitored at 2 weeks 4 weeks and then monthly Height gain and body composition using skin-fold thickness calipers and bioelectric impedance analysis will be assessed every 3 months Total energy expenditure three-day dietary history bone age body compositionbone mineral density using dual energy X-ray absorptiometry and laboratory studies IGF1 IGFBP3 pre-albumin transferrin ghrelin fasting insulin glucose and lipid profile will be obtained at baseline and then every 6 months
We hypothesize that nutritional supplementation alone can lead to small improvements in linear growth and lean body mass accrual but when combined with GH therapy can augment the anabolic actions of GH thereby resulting in even greater improvements in linear growth velocity and lean body mass accrual than GH alone If the data from this study confirm this trend we would then like to proceed with a larger study appropriately powered based on the results of this pilot
To investigate this further we would like to enroll a total of 20 boys 10-15 boys in Jacksonville Florida and 5-10 boys at the NIH Bethesda Maryland ages 7-10 years who are otherwise healthy but have significant short stature height SDS less than -225 the current FDA approved indication for the use of GH in idiopathic short stature delayed bone age greater than 12 months below chronologic age and low BMI and weight-for-height less than 25th percentile Ten boys will be randomized to receive observation for 6 months followed by GH therapy for 12 months Ten boys will be randomized to receive daily liquid nutritional supplementation for 6 months followed by combined GH therapy and nutritional supplementation for 12 months For all subjects weight gain will be monitored at 2 weeks 4 weeks and then monthly Height gain and body composition using skin-fold thickness calipers and bioelectric impedance analysis will be assessed every 3 months Total energy expenditure three-day dietary history bone age body compositionbone mineral density using dual energy X-ray absorptiometry and laboratory studies IGF1 IGFBP3 pre-albumin transferrin ghrelin fasting insulin glucose and lipid profile will be obtained at baseline and then every 6 months
We hypothesize that nutritional supplementation alone can lead to small improvements in linear growth and lean body mass accrual but when combined with GH therapy can augment the anabolic actions of GH thereby resulting in even greater improvements in linear growth velocity and lean body mass accrual than GH alone If the data from this study confirm this trend we would then like to proceed with a larger study appropriately powered based on the results of this pilot
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-0077 | None | None | None |