Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
NCT ID: NCT02397200
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2015-06-30
2025-03-31
Brief Summary
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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 female 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 female 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nutritional supplementation standardized formula
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 )
Nutritional supplementation standardized formula
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 )
Placebo comparator
Low caloric formula (Powder added to water), without added vitamins and minerals.
Placebo
Low caloric formula (Powder added to water), without added vitamins and minerals
Interventions
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Nutritional supplementation standardized formula
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 )
Placebo
Low caloric formula (Powder added to water), without added vitamins and minerals
Eligibility Criteria
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Inclusion Criteria
* Prepubertal - Tanner stage 1. (gonadarche) Breast at Tanner stage 1)
* Height and weight ≤ 10th percentile for age and gender.
* Height-SDS ≥ -2.5 SDS
* BMI-SDS\>-2 SDS
* Low proportion between weight and height
* Signing inform consent forms
Exclusion Criteria
* 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
* Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's).
9 Years
14 Years
FEMALE
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
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Soroka Medical Center
Beersheba, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Assaf Harofe
Rishon LeZiyyon, , Israel
Countries
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Other Identifiers
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rmc000214ctil
Identifier Type: -
Identifier Source: org_study_id
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