The purpose of the study is to find out if adding more calories to the diet helps young boys with growth problems grow better while being treated wtih growth hormone (GH).

Condition	Intervention	Phase
constitutional delay, short stature, growth hormone, nutrition and disorders of growth	Drug: Pediasure	Phase II

Further Study Details: 

Primary Outcomes: change in height,weight,body composition, energy usage.
Expected Total Enrollment:  20

2 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 for 6 months and then get GH shots every day for 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then GH shots plus this drink every day for the next 12 months. We will compare how well boys grow in height, weight and in the amount of muscle they develop. We will compare diet and energy usage. We will also compare the results of blood tests that tell us about growth and nutrition.

Ages Eligible for Study:  7 Years   -   10 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:boys 7-10 years old who are very short and below avarage in weight but otherwise healty. Delay in skeletal maturation > 1 year.

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Exclusion Criteria:Growth hormone deficency, chronic illness, participation in high endurance atheletics.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00139451

Susan R Welch, MSN, CPNP      904-858-3988    swelch@nemours.org
Nelly Mauras, MD      904-390-3674    nmauras@nemours.org

Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting

Study chairs or principal investigators

Nelly Mauras, MD,  Principal Investigator,  Nemours Children''''s Clinic   

Study ID Numbers:  IRB # 04-016
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139451
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06