Nutritional Stimulation of Growth in Children With Short Stature

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Growth Failure; Nutritional Stunting

Treatments: Dietary Supplement: Essential Amino Acid (EAA) group; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04226586

239581

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

* 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.

Treatment:

Dietary Supplement: Essential Amino Acid (EAA) group

Placebo

Placebo Comparator group

Description:

* 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.

Treatment:

Dietary Supplement: Placebo