Long Term Effects of Nutritional Supplementation on Final Height

Clalit Health Services

Status: Withdrawn

Conditions: Growth Disorders; Low Weight; Short Stature

Treatments: Other: Follow-up only; Dietary Supplement: Gender specific nutritional standardized formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03323177

RMC025117ctil

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15).
• Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15)
• Signing informed consent forme

Exclusion criteria

• Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nutritional supplementation gender specific formula

Experimental group

Description:

Patients at this arm will continue to consume the study formula until final height. The formula is a gender specific 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 (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake

Treatment:

Dietary Supplement: Gender specific nutritional standardized formula

Follow-up only

Other group

Description:

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

Treatment:

Other: Follow-up only