Long Term Effects of Nutritional Supplementation on Final Height

NCT03323177 | Withdrawn

• 1 other identifier: RMC025117ctil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.

Conditions

Growth Disorders; Low Weight; Short Stature

Outcome Measures

Primary Outcomes (1)

• Final Height Standardized Deviation Score (SDS)

  Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)

Secondary Outcomes (5)

• Weight Standard Deviation Score

  Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)

• Body Mass Index (BMI) Standard Deviation Score

  Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)

• Duration of puberty

  Up to 7 years (After reaching full puberty:tanner stage 5)

• Quality of Life

  Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)

• Self Esteem

  Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)

Study Arms (2)

Nutritional supplementation gender specific formula

EXPERIMENTAL

Patients at this arm will continue to consume the study formula until final height. The formula is a gender specific powder added to water containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake

Dietary Supplement: Gender specific nutritional standardized formula

Follow-up only

OTHER

Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached

Other: Follow-up only

Interventions

Gender specific nutritional standardized formula DIETARY_SUPPLEMENT

Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake

Nutritional supplementation gender specific formula

Follow-up only OTHER

Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached

Follow-up only

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15).
• Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15)
• Signing informed consent forme

You may not qualify if:

• Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone
• Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
• Any known gastrointestinal disease including malabsorption
• Any known organic reason for growth retardation
• Any chronic treatment with medication that might affect appetite, weight or growth

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Growth Disorders; Thinness; Dwarfism

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 26, 2017
• Study Start: June 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 27, 2019

Record last verified: 2018-04

Locations

IL (1)