Growth Failure, Nutritional Stunting
Conditions
Keywords
essential amino acids, short stature
Brief summary
Short stature is a frequent reason for referral to a pediatric endocrinology clinic. Short stature is especially prevalent among those with failure to thrive (whose weight is significantly below the average weight of his/her peers). The growth hormone has limited efficacy for medical treatment of short stature when the cause of short stature is not growth hormone deficiency. This study will investigate the effect of 6 months of nutritional supplement (essential amino acids) compared to placebo in the linear growth of short children who have not yet reached puberty.
Interventions
DIETARY_SUPPLEMENTEssential Amino Acid (EAA) group
Eligible children will be supplemented with Essential Amino Acids (EAA) for 6 months twice a day. Caution will be exercised to match the groups for age and sex.
DIETARY_SUPPLEMENTPlacebo
Eligible children will be supplemented with a placebo for 6 months twice a day. Caution will be exercised to match the groups for age and sex.
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 3 to 11 years (inclusive). * Pre-pubertal status (i.e. Tanner stage 1 for breast development for girls and testicular enlargement for boys and pubic hair for both sexes).
Exclusion criteria
* Ages younger than 3 years or older than 11 years. * Medical history of a neurologic, endocrinologic, genetic, or metabolic problem known to have a direct effect on height growth. This includes, but is not limited to, children with a Growth hormone deficiency, Down syndrome, Turner syndrome, Russel-Silver syndrome, Prader-Willi syndrome, Pseudohypoparathyroidism, chronic kidney disease, malabsorptive syndromes, cancer survivors, etc. * Currently being treated or previously treated with Growth hormone, or history of oral steroid treatment within the last 3 months. * Being in puberty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear Growth | 6 months | Growth velocity (cm/year) will be calculated and compared between arms using the height measurements taken before and after 6 months of Essential Amino Acids vs Placebo supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 6 months | Lean body mass will be measured using Dual X-Ray Absorptimetry (DXA) scan and compared between arms using the measurements taken before and after 6 months of Essential Amino Acids vs Placebo supplementation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum growth factor concentrations | 6 months | Serum concentration of Insulin-Like Growth-Factor (IGF)-I will be measured and compared between arms before and after 6 months of Essential Amino Acids vs Placebo supplementation. |
| Serum amino acid concentrations | 6 months | Serum amino acid concentrations will be measured and compared between arms before and after 6 months of Essential Amino Acids vs Placebo supplementation. |
Countries
United States
Outcome results
None listed