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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 March 2022 |
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Main ID: |
NCT02389803 |
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Date of registration:
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11/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
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Scientific title:
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Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02389803 |
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Study type:
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Interventional |
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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 |
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
10 Years
Age maximum:
15 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Short Stature
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Growth Problem
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Low Weight
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Intervention(s)
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Dietary Supplement: Nutritional supplementation standardized formula
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Dietary Supplement: Placebo comparator
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Primary Outcome(s)
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Height SDS (standard deviation score)
[Time Frame: At 6 months]
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Weight SDS (standard deviation score)
[Time Frame: At 12 months]
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Height SDS (standard deviation score)
[Time Frame: At 12 months]
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Weight SDS (standard deviation score)
[Time Frame: At 6 months]
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Secondary Outcome(s)
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BMI SDS (standard deviation score)
[Time Frame: At 6 months]
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Growth velocity
[Time Frame: At 6 months]
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Growth velocity
[Time Frame: At 12 months]
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Quality of life
[Time Frame: At 12 months]
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Quality of life
[Time Frame: At 6 months]
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Self-esteem (Self-Esteem Questionnaire)
[Time Frame: At 6 months]
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BMI SDS (standard deviation score)
[Time Frame: At 12 months]
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Self-esteem (Self-Esteem Questionnaire)
[Time Frame: At 12 months]
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Secondary ID(s)
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rmc067614ctil
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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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