Long Term Effects of Nutritional Supplementation on Final Height

Growth Disorders Clinical Trial

Official title:

Long Term Effects of Nutritional Supplementation on Final Height of Short and Lean Adolescents: Follow-up Study to One-year Double-blind, Randomized, Placebo Controlled Studies to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescent Boys and Girls

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03323177
• Other study ID #: RMC025117ctil
• Status: Withdrawn
• Phase: N/A
• Start date: June 2018
• Est. completion date: June 2022

Study information

• Verified date: April 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dwarfism
• Growth Disorders
• Low Weight
• Short Stature

Intervention

Dietary Supplement:
• Gender specific nutritional standardized formula
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

Other:
• Follow-up only
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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final Height Standardized Deviation Score (SDS)		Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary	Weight Standard Deviation Score		Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary	Body Mass Index (BMI) Standard Deviation Score		Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Secondary	Duration of puberty	Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5	Up to 7 years (After reaching full puberty:tanner stage 5)
Secondary	Quality of Life	Quality of life as measured through Quality of Life Questionnaire	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Secondary	Self Esteem	Self Esteem as measured through Self Esteem Questionnaire	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)