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Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls

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ClinicalTrials.gov Identifier: NCT02397200
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

Study design:

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


Condition or disease Intervention/treatment Phase
Growth Problem Low Weight Dietary Supplement: Nutritional supplementation standardized formula Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 )
Dietary Supplement: 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: Placebo comparator
Low caloric formula (Powder added to water), without added vitamins and minerals.
Dietary Supplement: Placebo
Low caloric formula (Powder added to water), without added vitamins and minerals




Primary Outcome Measures :
  1. Weight SDS (standard deviation score) [ Time Frame: At 12 months ]
    Standard deviation score of patient's weight at 12 months

  2. Height SDS (standard deviation score) [ Time Frame: At 12 months ]
    Standard deviation score of patient's height at 12 months

  3. Weight SDS (standard deviation score) [ Time Frame: At 6 months ]
    Standard deviation score of patient's weight at 6 months

  4. Height SDS (standard deviation score) [ Time Frame: At 6 months ]
    Standard deviation score of patient's height at 6 months


Secondary Outcome Measures :
  1. BMI SDS (standard deviation score) [ Time Frame: At 12 months ]
    Standard deviation score of patient's BMI at 12 months

  2. BMI SDS (standard deviation score) [ Time Frame: At 6 months ]
    Standard deviation score of patient's BMI at 6 months

  3. Growth velocity [ Time Frame: At 12 months ]
    Growth velocity measured as delta height divided by 12 months

  4. Growth velocity [ Time Frame: At 6 months ]
    Growth velocity measured as delta height divided by 6 months

  5. Quality of life Questionnaire [ Time Frame: At 12 months ]
    Quality of life measured by quality of life questionnaire

  6. Quality of life Questionnaire [ Time Frame: At 6 months ]
    Quality of life measured by quality of life questionnaire

  7. Self-esteem Questionnaire [ Time Frame: At 12 months ]
  8. Self-esteem Questionnaire [ Time Frame: At 6 months ]

Other Outcome Measures:
  1. Time to puberty initiation [ Time Frame: At 12 months ]
    Duration of time until breast at tanner stage >=2

  2. Sleep Assessment Questionnaire [ Time Frame: At 6 months ]
  3. Sleep Assessment Questionnaire [ Time Frame: At 12 months ]
  4. Physical Activity Questionnaire [ Time Frame: At 6 months ]
  5. Physical Activity Questionnaire [ Time Frame: At 12 months ]
  6. Study Participation Questionnaire [ Time Frame: At 6 months ]
  7. Study Participation Questionnaire [ Time Frame: At 12 months ]
  8. Family Eating and Activity Habits Questionnaire [ Time Frame: At 6 months ]
  9. Family Eating and Activity Habits Questionnaire [ Time Frame: At 12 months ]
  10. Parents Stands Towards Healty Lifestyle Questionnaire [ Time Frame: At 12 months ]
  11. Parents Stands Towards Healty Lifestyle Questionnaire [ Time Frame: At 6 months ]


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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Girls aged ≥9 years old
  • 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:

  • 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
  • Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397200


Contacts
Contact: Moshe Phillip, Prof 972-3-9253747 mosheph@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253778 alonah@clalit.org.il

Locations
Israel
Soroka Medical Center Recruiting
Be'er Sheva`, Israel
Contact: Eli Hershkovitz, MD       elih@bgu.ac.il   
Principal Investigator: Eli Hershkovitz, MD         
Schneider Children's Medical Center Recruiting
Petach-Tikva, Israel, 49202
Contact: Moshe Phillip, Prof    972-3-9253747    mosheph@clalit.org.il   
Contact: Alona Hamou, Msc    972-3-9253778    alonah@clalit.org.il   
Principal Investigator: Moshe Phillip, Prof         
Sub-Investigator: Liora Lazar, Prof         
Sub-Investigator: Liat De Vreis, Dr.         
Sub-Investigator: Shlomit Shalitin, Prof         
Sub-Investigator: Yael Levental, Dr         
Sub-Investigator: Ariel Tenenbaum, Dr.         
Sub-Investigator: Ravital Nimri, Dr.         
Sub-Investigator: Avivit Brener, Dr         
Sub-Investigator: Tal Oron, Dr         
Sub-Investigator: Rachel Bello, Dr         
Sub-Investigator: Demol Sharon, Dr         
Sub-Investigator: Naama Fish, Dr         
Sub-Investigator: Marie Mouler, Dr         
Assaf Harofe Recruiting
Rishon Letsiyon, Israel
Contact: Marianna Rachmiel, MD    972-8-9542007      
Principal Investigator: Marianna Rachmiel, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Prof Schneider Children's Medical Center

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02397200     History of Changes
Other Study ID Numbers: rmc000214ctil
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Rabin Medical Center:
Growth
low weight
low height
Nutritional Supplementation

Additional relevant MeSH terms:
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs