Nutritional Stimulation of Growth in Children With Short Stature

Growth Failure Clinical Trial

Official title:

Nutritional Stimulation of Growth in Children With Short Stature

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226586
• Other study ID #: 239581
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dwarfism
• Failure to Thrive
• Growth Failure
• Nutritional Stunting

Intervention

Dietary Supplement:
• Essential Amino Acid (EAA) group
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Emir Tas	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	6 months
Other	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
Primary	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
Secondary	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
Secondary	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.	6 months
Secondary	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