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

NCT02389803 | Completed

• 1 other identifier: rmc067614ctil
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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 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

Conditions

Growth Problem; Low Weight; Short Stature

Outcome Measures

Primary Outcomes (4)

• Weight SDS (standard deviation score)

  At 12 months

• Height SDS (standard deviation score)

  At 12 months

• Weight SDS (standard deviation score)

  At 6 months

• Height SDS (standard deviation score)

  At 6 months

Secondary Outcomes (8)

• BMI SDS (standard deviation score)

  At 12 months

• BMI SDS (standard deviation score)

  At 6 months

• Growth velocity

  At 12 months

• Growth velocity

  At 6 months

• Quality of life

  At 12 months

Other Outcomes (10)

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

  At 12 months

• Sleep assessment Questionnaire

  At 12 Months

• Sleep assessment Questionnaire

  At 6 Months

Study Arms (2)

Nutritional supplementation standardized formula

EXPERIMENTAL

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 )

Dietary Supplement: Nutritional supplementation standardized formula

Placebo comparator

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo comparator

Interventions

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 )

Nutritional supplementation standardized formula

Placebo comparator DIETARY_SUPPLEMENT

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

Placebo comparator

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (3)

Soroka Medical Center

Beersheba, Israel

Location

Schneider Medical Center

Petah Tikva, 49202, Israel

Location

Assaf Harofe Medical Center

Rishon LeZiyyon, Israel

Location

MeSH Terms

Conditions

Thinness; Dwarfism

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Moshe Phillip, Prof

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 22, 2022

Record last verified: 2019-12

Locations

IL (3)