Skip to main content
OpenTrials
Completed

NCT Number: NCT02389803

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

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 boys 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 boys 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Problem Body Weight Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Low Weight Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Short Stature Signs and Symptoms Thinness

Age range

10 year–15 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center, Beersheba, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nutritional supplementation standardized formula

Dietary Supplement

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 )

Placebo Comparator

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

  2. Height SDS (standard deviation score)

    Time frame: At 12 months

  3. Weight SDS (standard deviation score)

    Time frame: At 6 months

  4. Height SDS (standard deviation score)

    Time frame: At 6 months

Secondary outcomes

  1. BMI SDS (standard deviation score)

    Time frame: At 12 months

  2. BMI SDS (standard deviation score)

    Time frame: At 6 months

  3. Growth velocity

    Time frame: At 12 months

  4. Growth velocity

    Time frame: At 6 months

  5. Quality of life

    Time frame: At 12 months

    Quality of life measured by Quality of Life Questionnaire

  6. Quality of life

    Time frame: At 6 months

    Quality of life measured by Quality of Life Questionnaire

  7. Self-esteem (Self-Esteem Questionnaire)

    Time frame: At 12 months

    Self-esteem measured by Self-Esteem Questionnaire

  8. Self-esteem (Self-Esteem Questionnaire)

    Time frame: At 6 months

    Self-esteem measured by Self-Esteem Questionnaire

Other outcomes

  1. Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2)

    Time frame: At 12 months

    Duration of time until testicular volume is at tanner stage >=2

  2. Sleep assessment Questionnaire

    Time frame: At 12 Months

  3. Sleep assessment Questionnaire

    Time frame: At 6 Months

  4. Physical Activity Questionnaire

    Time frame: At 12 months

  5. Study Participation Questionnaire

    Time frame: At 6 months

  6. Study Participation Questionnaire

    Time frame: At 12 months

  7. Family Eating and Activity Habits Questionnaire

    Time frame: At 6 months

  8. Family Eating and Activity Habits Questionnaire

    Time frame: At 12 months

  9. Parents Stands Towards Healthy Lifestyle Questionnaire

    Time frame: At 6 months

  10. Parents Stands Towards Healthy Lifestyle Questionnaire

    Time frame: At 12 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 Boys

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2015
Registry last updated
Feb 22, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.