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NCT Number: NCT02397200

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

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

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Key information

Conditions

Growth Problem Body Weight Low Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness

Age range

9 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center, Beersheba, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nutritional supplementation standardized formula

Dietary Supplement

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

Dietary Supplement

Low caloric formula (Powder added to water), without added vitamins and minerals

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2015
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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