An interventional study of Essential Amino Acid (EAA) group and Placebo in Nutritional Stunting and Growth Failure, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 3 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Treatment
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* This is a double-blind study. Participants and the investigators will be blinded to the intervention. * Children in the treatment (intervention) arm will receive essential amino acids (EAA) twice a day. * Children 3 to 5 years of age will be asked to take either 8.5 g (1 serving) of EAA supplement or placebo at breakfast and at bedtime. * Children 6 to 11 years of age will be assigned to take either 17 g (2 servings) of EAA supplement or placebo at breakfast and at bedtime. * EAA and placebo dissolve easily in any liquid beverage and can be taken on empty versus full stomach.
Dietary Supplement: Essential Amino Acid (EAA) group
* This is a double-blind study. Participants and the investigators will be blinded to the intervention. * Children in the placebo arm will receive placebo twice a day. EAA and placebo supplements will look and taste alike. The same flavoring ingredients (stevia blend, citric acid, malic acid, natural flavors, tartaric acid, fruit and vegetable juice for color) will be used in both products at the same amount. * Children 3 to 5 years of age will be asked to take either 8.5 g (1 serving) of EAA supplement or placebo at breakfast and at bedtime. * Children 6 to 11 years of age will be assigned to take either 17 g (2 servings) of EAA supplement or placebo at breakfast and at bedtime. * EAA and placebo dissolve easily in any liquid beverage and can be taken on empty versus full stomach.
Dietary Supplement: Placebo
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.
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
Body Composition
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 6 months
Serum growth factor concentrations
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.
Time frame: 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.
Time frame: 6 months
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Essential amino acid
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