Nutritional Stimulation of Growth in Children With Short Stature

NCT ID: NCT04226586

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

• 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 Type: ACTIVE_COMPARATOR

Essential Amino Acid (EAA) group

Intervention Type: 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.

Placebo

• 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emir Tas, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Research Insitute

Locations

Emir Tas

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

239581

Identifier Type: -

Identifier Source: org_study_id