Back to resultsLong Term Effects of Nutritional Supplementation on Final Height
Primary Purpose
Growth Disorders, Low Weight, Short Stature
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gender specific nutritional standardized formula
Follow-up only
Sponsored by
About this trial
This is an interventional treatment trial for Growth Disorders
Eligibility Criteria
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
Sites / Locations
- Schneider Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Nutritional supplementation gender specific formula
Follow-up only
Arm Description
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
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
Outcomes
Primary Outcome Measures
Final Height Standardized Deviation Score (SDS)
Secondary Outcome Measures
Weight Standard Deviation Score
Body Mass Index (BMI) Standard Deviation Score
Duration of puberty
Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Quality of Life
Quality of life as measured through Quality of Life Questionnaire
Self Esteem
Self Esteem as measured through Self Esteem Questionnaire
Full Information
NCT ID
NCT03323177
First Posted
October 3, 2017
Last Updated
December 26, 2019
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03323177
Brief Title
Long Term Effects of Nutritional Supplementation on Final Height
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
finally it was decided not to initiate the study due to logistical issues
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorders, Low Weight, Short Stature
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional supplementation gender specific formula
Arm Type
Experimental
Arm Description
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
Arm Title
Follow-up only
Arm Type
Other
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Gender specific nutritional standardized formula
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Follow-up only
Intervention Description
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
Primary Outcome Measure Information:
Title
Final Height Standardized Deviation Score (SDS)
Time Frame
Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary Outcome Measure Information:
Title
Weight Standard Deviation Score
Time Frame
Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Title
Body Mass Index (BMI) Standard Deviation Score
Time Frame
Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Title
Duration of puberty
Description
Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Time Frame
Up to 7 years (After reaching full puberty:tanner stage 5)
Title
Quality of Life
Description
Quality of life as measured through Quality of Life Questionnaire
Time Frame
Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Title
Self Esteem
Description
Self Esteem as measured through Self Esteem Questionnaire
Time Frame
Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schneider Children's Medical Center
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
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Long Term Effects of Nutritional Supplementation on Final Height
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