Growth DisordersNCT03323177
Long Term Effects of Nutritional Supplementation on Final Height
A study testing Gender specific nutritional standardized formula and Follow-up only in people with Growth Disorders and Low Weight, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Growth Disorders, Low Weight, Short Stature
- What is being tested?
- Gender specific nutritional standardized formula and Follow-up only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2018to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Gender specific nutritional standardized formula, Follow-up only
- Medical subject headings
- Growth Disorders, Thinness, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender specific nutritional standardized formulaDietary 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
Follow-up onlyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Follow-up only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Height Standardized Deviation Score (SDS)
Measured: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary outcomes (5)
Weight Standard Deviation Score
Measured: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Body Mass Index (BMI) Standard Deviation Score
Measured: Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Duration of puberty
Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Measured: Up to 7 years (After reaching full puberty:tanner stage 5)
Quality of Life
Quality of life as measured through Quality of Life Questionnaire
Measured: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Self Esteem
Self Esteem as measured through Self Esteem Questionnaire
Measured: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startJun 2018 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: finally it was decided not to initiate the study due to logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323177
- Sponsor's protocol ID
- RMC025117ctil
- Status last verified
- Apr 2018
- First submitted
- 3 Oct 2017
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03323177
- Acronym / sponsor ID
- RMC025117ctil
- Conditions
- Growth Disorders, Low Weight, Short Stature
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: finally it was decided not to initiate the study due to logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplementation gender specific formula | Experimental | Dietary Supplement: Gender specific nutritional standardized formulaPatients 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 |
| Follow-up only | Other | Other: Follow-up onlyPatients 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 |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gender specific nutritional standardized formulaPatients 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 | Dietary supplement | Nutritional supplementation gender specific formula |
| Follow-up onlyPatients 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 |
Primary outcome
Final Height Standardized Deviation Score (SDS)
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
5 secondary outcomes
Weight Standard Deviation Score
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
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)
Duration of puberty
Time frame: Up to 7 years (After reaching full puberty:tanner stage 5)
Quality of Life
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Self Esteem
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gender specific nutritional standardized formula and Follow-up only in people with Growth Disorders and Low Weight, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Height Standardized Deviation Score (SDS) (time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.