Nutritional Stimulation of Growth in Children With Short Stature

Not Applicable

Completed

• Conditions: Nutritional Stunting; Growth Failure

• Registration Number: NCT04226586
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-09-09
• Primary Completion: 2022-03-15
• Status Verified: 2022-06
• Study Completion: 2022-12-31
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body Composition	6 months	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.

Trial Locations

Locations (1)

Emir Tas; 🇺🇸 Little Rock, Arkansas, United States