Nutritional Stimulation of Growth in Children With Short Stature

N/A

Waitlist Available

Led By Emir Tas, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial is testing whether a nutritional supplement with essential amino acids can help short children who haven't reached puberty grow taller. These children often have lower weight compared to their peers and don't respond well to growth hormone treatments. The supplement provides important nutrients that might help their bodies grow better.

Eligible Conditions

Nutritional Stunting
Growth Delay

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Linear Growth

Secondary study objectives

Body Composition

Other study objectives

Serum amino acid concentrations

Serum growth factor concentrations

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment GroupActive Control1 Intervention

* 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.

Group II: PlaceboPlacebo Group1 Intervention

* 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.

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