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Nutritional Stimulation of Growth in Children With Short Stature

Primary Purpose

Nutritional Stunting, Growth Failure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Essential Amino Acid (EAA) group
Placebo
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional Stunting focused on measuring essential amino acids, short stature

Eligibility Criteria

3 Years - 11 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Emir Tas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Group

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 7, 2020
Last Updated
June 1, 2022
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04226586
Brief Title
Nutritional Stimulation of Growth in Children With Short Stature
Official Title
Nutritional Stimulation of Growth in Children With Short Stature
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Stunting, Growth Failure
Keywords
essential amino acids, short stature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Essential Amino Acid (EAA) group
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Linear Growth
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body Composition
Description
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.
Time Frame
6 months
Title
Body Composition
Description
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.
Time Frame
6 months
Title
Body Composition
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Serum growth factor concentrations
Description
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.
Time Frame
6 months
Title
Serum growth factor concentrations
Description
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.
Time Frame
6 months
Title
Serum amino acid concentrations
Description
Serum amino acid concentrations will be measured and compared between arms before and after 6 months of Essential Amino Acids vs Placebo supplementation.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emir Tas, MD
Organizational Affiliation
Arkansas Children's Research Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emir Tas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

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Nutritional Stimulation of Growth in Children With Short Stature

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