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

Clalit Health Services

Status: Completed

Conditions: Low Weight; Growth Problem; Short Stature

Treatments: Dietary Supplement: Nutritional supplementation standardized formula; Dietary Supplement: Placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT02389803

rmc067614ctil

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: Male

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Nutritional supplementation standardized formula

Experimental group

Description:

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 )

Treatment:

Dietary Supplement: Nutritional supplementation standardized formula

Placebo comparator

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo comparator