Status:
COMPLETED
Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children
Lead Sponsor:
Rabin Medical Center
Conditions:
Growth
Low Weight
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
Study design: Double blind, randomized, placebo controlled study.The proposed study will consist of two main segments: 1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutrit...
Eligibility Criteria
Inclusion
- Inclusion Criteria for participants at the intervention group (segments 1\&2):
- Girls aged 3-7 years old and boys aged 3-8 years old
- Prepubertal - tanner stage 1
- Height, weight and BMI \< 10th percentile for age and gender
- Availability of growth velocity data for at least 4 months prior to study entry.
- Signing inform consent forms
- Exclusion Criteria for participants at the intervention group (segments 1):
- Diagnosis of 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 cardial, renal or pulmonary problems
- Any known gastrointestinal problem including absorption problems
- Any known organic reason for slow growth
- Any chronic treatment with medication that might effects appetite (for example SSRI's), weight or Growth.
- Inclusion Criteria for participants at the control group (segments 2):
- Girls aged 3-8 years old and boys aged 3-9 years old
- Prepubertal - tanner stage 1
- Height ≥ 25th percentile for age and gender
- Proper proportion between weight and height- 5th ≤ BMI ≤ 85th
- Signing inform consent forms
- Exclusion Criteria for participants at the control group (segments 2):
- Diagnosis of 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 cardial, renal or pulmonary problems
- Any known gastrointestinal problem including absorption problems
- Any known organic reason for slow growth
- Any chronic treatment with medication that might effects appetite (for example SSRI's), weight or Growth
- Children with growth faltering during the previous year
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01158352
Start Date
November 1 2010
End Date
November 1 2014
Last Update
November 7 2014
Active Locations (1)
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1
Schneider Children's Medical center
Petaach-Tikva, Israel, 49202