IGHD - Isolated Growth Hormone DeficiencyNCT03053687
Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy
A study testing Nutritional supplementation standardized formula in people with IGHD - Isolated Growth Hormone Deficiency and Growth Retardation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The Proposed study is a double blind, randomized, placebo controlled study The aim of the study is to evaluate the effect of combined Growth Hormone (GH) treatment \& nutritional formula supplementation versus GH \& placebo on growth parameters in 64 children with Isolated Growth Hormone Deficiency (IGHD) after the… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- IGHD - Isolated Growth Hormone Deficiency, Growth Retardation
- What is being tested?
- Nutritional supplementation standardized formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to Oct 2024
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml
- Boys: testicular volume < 8ml; Girls: breast ≤ Tanner 3
- weight SDS < 0
- BMI SDS < 50 precentile for age and gender
- Signing inform consent forms
Who cannot join
- Other indication for GH treatment.
- Bone age: boys>13.5, girls>11.5.
- Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders.
- Any known gastrointestinal problem including absorption problems.
- Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use
- Any eating disorders and/or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schnider children's medical center
Petah Tikva, 49202
Moshe Phillip, Professor, 972-3-9253778, mosheph@clalit.org.il
Moshe Phillip, Prof
About this study
Official title: Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled Trial
The Proposed study is a double blind, randomized, placebo controlled study The aim of the study is to evaluate the effect of combined Growth Hormone (GH) treatment \& nutritional formula supplementation versus GH \& placebo on growth parameters in 64 children with Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.
In this trial GH is a background treatment (non-investigational medicinal product. Participants may be treated with any of the commercial GH products approved in Israel for the indication of IGHD.
Read more
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. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender and tanner stage.
Participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (Powder added to water) The study will continue for 6 months of intervention versus active placebo, with additional 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 active study supplement.
- Being tested
- Nutritional supplementation standardized formula, Placebo
- Medical subject headings
- Dwarfism, Pituitary
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 Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
PlaceboDietary supplement
Low caloric formula (Powder added to water) without added vitamins and mineral
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Standardized Supplementation Formula | Experimental | Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake Receives: Dietary Supplement: Nutritional supplementation standardized formula |
| Placebo | Placebo comparator | Low caloric formula (Powder added to water) without added vitamins and mineral Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Standard Deviation Score (SDS)
Measured: at 6 months
Secondary outcomes (3)
Height-SDS
Measured: at 12 months
Weight SDS
Measured: at 12 months
BMI SDS
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Nov 2017
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGHD - Isolated Growth Hormone DeficiencyStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, MD, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053687
- Sponsor's protocol ID
- rmc082116ctil
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2017
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03053687
- Acronym / sponsor ID
- rmc082116ctil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Feb 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 a double blind, randomized, placebo controlled study The aim of the study is to evaluate the effect of combined Growth Hormone (GH) treatment \& nutritional formula supplementation versus GH \& placebo on growth parameters in 64 children with Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.
In this trial GH is a background treatment (non-investigational medicinal product. Participants may be treated with any of the commercial GH products approved in Israel for the indication of IGHD.
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. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender and tanner stage.
Participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (Powder added to water) The study will continue for 6 months of intervention versus active placebo, with additional 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 active study supplement.
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 Standardized Supplementation 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 multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboLow caloric formula (Powder added to water) without added vitamins and mineral |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml
- Boys: testicular volume < 8ml; Girls: breast ≤ Tanner 3
- weight SDS < 0
- BMI SDS < 50 precentile for age and gender
- Signing inform consent forms
Key exclusion criteria (6 listed)
- Other indication for GH treatment.
- Bone age: boys>13.5, girls>11.5.
- Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders.
- Any known gastrointestinal problem including absorption problems.
- Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use
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 Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake | Dietary supplement | Nutritional Standardized Supplementation Formula |
| PlaceboLow caloric formula (Powder added to water) without added vitamins and mineral | Dietary supplement | Placebo |
Primary outcome
Weight Standard Deviation Score (SDS)
Time frame: at 6 months
3 secondary outcomes
Height-SDS
Time frame: at 12 months
Weight SDS
Time frame: at 12 months
BMI SDS
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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, MD principal investigator
Schneider Children's Medical Center
1 site 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 IGHD - Isolated Growth Hormone Deficiency and Growth Retardation, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Phillip, Prof, MD (972-3-9253282, mosheph@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Standard Deviation Score (SDS) (time frame: at 6 months). 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 26 Mar 2024.