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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential Amino Acid (EAA) group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Linear Growth | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | 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. | 6 months |
| Body Composition |
| Measure | Description | Time Frame |
|---|---|---|
| Serum growth factor concentrations | 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. | 6 months |
| Serum growth factor concentrations |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emir Tas, MD | Arkansas Children's Research Insitute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emir Tas | Little Rock | Arkansas | 72202 | United States |
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| ID | Term |
|---|---|
| D005183 | Failure to Thrive |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D000601 | Amino Acids, Essential |
| D018846 | Excitatory Amino Acids |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Placebo | Dietary Supplement | 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. |
|
Body fat 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. |
| 6 months |
| Body Composition | Visceral fat 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. | 6 months |
Serum concentration of Insulin-Like Growth-Factor Binding-Protein (IGF BP)-III will be measured and compared between arms before and after 6 months of Essential Amino Acids vs Placebo supplementation. |
| 6 months |
| Serum amino acid concentrations | Serum amino acid concentrations will be measured and compared between arms before and after 6 months of Essential Amino Acids vs Placebo supplementation. | 6 months |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |