An interventional study of Gender specific nutritional standardized formula and Follow-up only in Growth Disorders, Low Weight and Short Stature, sponsored by Rabin Medical Center. Withdrawn at 1 site in Israel. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
Browse Growth Disorders studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Gender specific nutritional standardized formula
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
Other: Follow-up only
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
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
Final Height Standardized Deviation Score (SDS)
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Weight Standard Deviation Score
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Body Mass Index (BMI) Standard Deviation Score
Time frame: Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Duration of puberty
Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Time frame: Up to 7 years (After reaching full puberty:tanner stage 5)
Quality of Life
Quality of life as measured through Quality of Life Questionnaire
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Self Esteem
Self Esteem as measured through Self Esteem Questionnaire
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Start is estimated for Jun 2018; primary completion for Jun 2022, 48 months later.
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This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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