NCT03323177

Long Term Effects of Nutritional Supplementation on Final Height

Long Term Effects of Nutritional Supplementation on Final Height of Short and Lean Adolescents: Follow-up Study to One-year Double-blind, Randomized, Placebo Controlled Studies to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescent Boys and Girls

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.

Conditions

• Growth Disorders
• Low Weight
• Short Stature

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gender specific nutritional standardized formula	Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
OTHER	Follow-up only	Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2017-10-26
• Last updated: 2019-12-27

Locations

1 site across 1 country: Israel