Nutritional Stimulation of Growth in Children With Short Stature
Nutritional Stunting, Growth Failure
About this trial
This is an interventional treatment trial for Nutritional Stunting focused on measuring essential amino acids, short stature
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.
Sites / Locations
- Emir Tas
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Treatment Group
Placebo
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.
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.