Nutritional Stimulation of Growth in Children With Short Stature

NCT04226586 | Completed

• 1 other identifier: 239581
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Stunting; Growth Failure

Keywords

essential amino acids; short stature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Body Composition

  6 months

• Body Composition

  6 months

• Body Composition

  6 months

Other Outcomes (3)

• Serum growth factor concentrations

  6 months

• Serum growth factor concentrations

  6 months

• Serum amino acid concentrations

  6 months

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

* 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

Placebo

PLACEBO COMPARATOR

* 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

Interventions

Essential Amino Acid (EAA) group DIETARY_SUPPLEMENT

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.

Treatment Group

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Emir Tas

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Failure to Thrive; Dwarfism

Interventions

Amino Acids, Essential; Excitatory Amino Acids; Population Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Demography; Population Characteristics

Study Officials

• Emir Tas, MD

  Arkansas Children's Research Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: September 9, 2020
• Primary Completion: March 15, 2022
• Study Completion: December 31, 2022
• Last Updated: July 31, 2024

Record last verified: 2022-06

Locations

US (1)