Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 April 2024 |
Main ID: |
NCT03053687 |
Date of registration:
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07/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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November 1, 2017 |
Target sample size:
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64 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03053687 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Moshe Phillip, Prof, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Schneider Children's Medical Center |
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Name:
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Moshe Phillip, Professor |
Address:
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Telephone:
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972-3-9253778 |
Email:
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mosheph@clalit.org.il |
Affiliation:
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Name:
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Moshe Phillip, Prof, MD |
Address:
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Telephone:
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972-3-9253282 |
Email:
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mosheph@clalit.org.il |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
3 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Retardation
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IGHD - Isolated Growth Hormone Deficiency
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Intervention(s)
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Dietary Supplement: Nutritional supplementation standardized formula
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Weight Standard Deviation Score (SDS)
[Time Frame: at 6 months]
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Secondary Outcome(s)
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Weight SDS
[Time Frame: at 12 months]
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Height-SDS
[Time Frame: at 12 months]
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BMI SDS
[Time Frame: at 12 months]
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Secondary ID(s)
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rmc082116ctil
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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