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Amino Acid Supplement

Treatment Group for Nutritional Stunting

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
Awards & highlights

Study Summary

This trial will investigate whether 6 months of essential amino acids can help with the linear growth of short children who have not reached puberty, compared to a placebo.

Eligible Conditions
  • Nutritional Stunting
  • Growth Delay

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Linear Growth
Secondary outcome measures
Body Composition
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,329 Total Patients Enrolled
Arkansas Children's Hospital Research InstituteLead Sponsor
135 Previous Clinical Trials
5,029,341 Total Patients Enrolled
Emir Tas, MDPrincipal InvestigatorArkansas Children's Research Insitute
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific qualifications for participating in this research?

"This research project is currently enrolling 24 minors, aged between 3 and 11. Furthermore, those interested must meet the pre-pubertal status requirements such as Tanner stage 1 for breast development in girls or testicular enlargement in boys."

Answered by AI

Is there an ongoing enrollment period for this experiment?

"Clinicaltrials.gov indicates that this research trial is not currently accepting participants. It was posted on September 9th 2020 and last edited on June 1st 2022, though there are 24 other trials actively seeking out candidates."

Answered by AI

Does this experiment account for geriatric patients?

"This clinical trial's eligibility requirements stipulate that only patients aged 3 to 11 can be enrolled. Additionally, there are 22 trials available for individuals under 18 and 6 studies open to adults over 65 years of age."

Answered by AI

Who else is applying?

What site did they apply to?
Arkansas Children's Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nutritional Stimulation of Growth in Children With Short Stature
2020. "Nutritional Stimulation of Growth in Children With Short Stature". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04226586.
~5 spots leftby Apr 2025
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