Short Stature Clinical Trial
Official title:
Nutrients and Hormones: Effects in Boys With Disordered Growth - Pilot Study
Verified date | October 2, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Children's 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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 7 Years to 10 Years |
Eligibility |
- INCLUSION CRITERIA Age 7-10 years, genital Tanner 1, significant short stature (current height less than 2.25SD below the mean for age), body mass index (BMI) less than 25th percentile for age, weight-for-height less than 25th percentile, bone age less than 10 years and with delay greater than 1 year below chronological age, minimum of 6 months of documented height measurements performed in the pediatric endocrinology clinic using a stadiometer to permit accurate calculation of baseline growth velocity at time of enrollment, otherwise normal physical exam, expressed desire for medical intervention to promote growth, and assessment by a pediatric endocrinologist that the boy qualifies for GH treatment according to current FDA guidelines for the use of GH in children with idiopathic short stature (i.e., children who are determined not to have growth hormone deficiency but have height less than -2.25SD below the mean for age). EXCLUSION CRITERIA History of major/chronic illness, anosmia/hyposmia, any clinically significant abnormalities on biochemical testing. GH deficiency would be excluded prior to enrollment based on anthropometric and GH stimulation test data. Endocrinopathies (except stable thyroid replacement), skeletal dysplasias, participation in highly competitive endurance sports activities, diagnosis of ADHD with use of stimulant medication in the previous 3 months will also be exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Leschek EW, Rose SR, Yanovski JA, Troendle JF, Quigley CA, Chipman JJ, Crowe BJ, Ross JL, Cassorla FG, Blum WF, Cutler GB Jr, Baron J; National Institute of Child Health and Human Development-Eli Lilly & Co. Growth Hormone Collaborative Group. Effect of growth hormone treatment on adult height in peripubertal children with idiopathic short stature: a randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2004 Jul;89(7):3140-8. — View Citation
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