Growth ProblemNCT02389803
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
A study testing Nutritional supplementation standardized formula in people with Growth Problem and Low Weight, run by Rabin Medical Center at 3 sites in Israel.
Trial summary
Study design: Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Read more about this study
- Who is it for?
- Ages 10 to 15 years, men only
- Conditions the study is for
- Growth Problem, Low Weight, Short Stature
- What is being tested?
- Nutritional supplementation standardized formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesIsrael
- Study dates
- Jun 2015to 1 Feb 2021
- 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Boys aged ≥10years old
- Prepubertal - Tanner stage 1 (gonadarche) (testicular volume<4)
- Height and weight ≤ 10th percentile for age and gender.
- Height-SDS ≥ -2.5 SDS
- BMI-SDS>-3 SDS
- Low proportion between weight and height
- Signing inform consent forms
Who cannot join
- Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Soroka Medical Center
Beersheba
Schneider Medical Center
Petah Tikva, 49202
Assaf Harofe Medical Center
Rishon LeZiyyon
About this study
Official title: Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Study design:
Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1.
The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo
- Conditions
- Growth Problem, Low Weight, Short Stature
- Being tested
- Nutritional supplementation standardized formula, Placebo comparator
- Medical subject headings
- Thinness, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementation standardized formulaDietary supplement
Powder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake )
Placebo comparatorDietary supplement
Low caloric formula (Powder added to water), without added vitamins and minerals
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplementation standardized formula | Experimental | 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 (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ) Receives: Dietary Supplement: Nutritional supplementation standardized formula |
| Placebo comparator | Placebo comparator | Low caloric formula (Powder added to water), without added vitamins and mineral Receives: Dietary Supplement: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight SDS (standard deviation score)
Measured: At 12 months
Height SDS (standard deviation score)
Measured: At 12 months
Weight SDS (standard deviation score)
Measured: At 6 months
Height SDS (standard deviation score)
Measured: At 6 months
Secondary outcomes (8)
BMI SDS (standard deviation score)
Measured: At 12 months
BMI SDS (standard deviation score)
Measured: At 6 months
Growth velocity
Measured: At 12 months
Growth velocity
Measured: At 6 months
Quality of life
Quality of life measured by Quality of Life Questionnaire
Measured: At 12 months
Quality of life
Quality of life measured by Quality of Life Questionnaire
Measured: At 6 months
Self-esteem (Self-Esteem Questionnaire)
Self-esteem measured by Self-Esteem Questionnaire
Measured: At 12 months
Self-esteem (Self-Esteem Questionnaire)
Self-esteem measured by Self-Esteem Questionnaire
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth ProblemStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389803
- Sponsor's protocol ID
- rmc067614ctil
- Status last verified
- Dec 2019
- First submitted
- 11 Mar 2015
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
- ClinicalTrials.gov ID
- NCT02389803
- Acronym / sponsor ID
- rmc067614ctil
- Conditions
- Growth Problem, Low Weight, Short Stature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Study design:
Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1.
The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplementation standardized formula | Experimental | Dietary Supplement: Nutritional supplementation standardized formulaPowder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ) |
| Placebo comparator | Placebo comparator | Dietary Supplement: Placebo comparatorLow caloric formula (Powder added to water), without added vitamins and mineral |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Boys aged ≥10years old
- Prepubertal - Tanner stage 1 (gonadarche) (testicular volume<4)
- Height and weight ≤ 10th percentile for age and gender.
- Height-SDS ≥ -2.5 SDS
- BMI-SDS>-3 SDS
Key exclusion criteria (4 listed)
- Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
- 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
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 |
|---|---|---|
| Nutritional supplementation standardized formulaPowder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ) | Dietary supplement | Nutritional supplementation standardized formula |
| Placebo comparatorLow caloric formula (Powder added to water), without added vitamins and minerals | Dietary supplement | Placebo comparator |
Primary outcome
Weight SDS (standard deviation score)
Time frame: At 12 months
Height SDS (standard deviation score)
Time frame: At 12 months
Weight SDS (standard deviation score)
Time frame: At 6 months
Height SDS (standard deviation score)
Time frame: At 6 months
8 secondary outcomes
BMI SDS (standard deviation score)
Time frame: At 12 months
BMI SDS (standard deviation score)
Time frame: At 6 months
Growth velocity
Time frame: At 12 months
Growth velocity
Time frame: At 6 months
Quality of life
Time frame: At 12 months
Quality of life
Time frame: At 6 months
Self-esteem (Self-Esteem Questionnaire)
Time frame: At 12 months
Self-esteem (Self-Esteem Questionnaire)
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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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.
Moshe Phillip, Prof principal investigator
Schneider Children's Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation standardized formula in people with Growth Problem and Low Weight, run by Rabin Medical Center at 3 sites 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight SDS (standard deviation score) (time frame: At 12 months). The study lists 4 primary outcomes in all. 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 22 Feb 2022.