Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-29 @ 2:28 AM
Study NCT ID:
NCT02389803
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013851', 'term': 'Thinness'}, {'id': 'D004392', 'term': 'Dwarfism'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2)', 'timeFrame': 'At 12 months', 'description': 'Duration of time until testicular volume is at tanner stage \\>=2'}, {'measure': 'Sleep assessment Questionnaire', 'timeFrame': 'At 12 Months'}, {'measure': 'Sleep assessment Questionnaire', 'timeFrame': 'At 6 Months'}, {'measure': 'Physical Activity Questionnaire', 'timeFrame': 'At 12 months'}, {'measure': 'Study Participation Questionnaire', 'timeFrame': 'At 6 months'}, {'measure': 'Study Participation Questionnaire', 'timeFrame': 'At 12 months'}, {'measure': 'Family Eating and Activity Habits Questionnaire', 'timeFrame': 'At 6 months'}, {'measure': 'Family Eating and Activity Habits Questionnaire', 'timeFrame': 'At 12 months'}, {'measure': 'Parents Stands Towards Healthy Lifestyle Questionnaire', 'timeFrame': 'At 6 months'}, {'measure': 'Parents Stands Towards Healthy Lifestyle Questionnaire', 'timeFrame': 'At 12 months'}], 'primaryOutcomes': [{'measure': 'Weight SDS (standard deviation score)', 'timeFrame': 'At 12 months'}, {'measure': 'Height SDS (standard deviation score)', 'timeFrame': 'At 12 months'}, {'measure': 'Weight SDS (standard deviation score)', 'timeFrame': 'At 6 months'}, {'measure': 'Height SDS (standard deviation score)', 'timeFrame': 'At 6 months'}], 'secondaryOutcomes': [{'measure': 'BMI SDS (standard deviation score)', 'timeFrame': 'At 12 months'}, {'measure': 'BMI SDS (standard deviation score)', 'timeFrame': 'At 6 months'}, {'measure': 'Growth velocity', 'timeFrame': 'At 12 months'}, {'measure': 'Growth velocity', 'timeFrame': 'At 6 months'}, {'measure': 'Quality of life', 'timeFrame': 'At 12 months', 'description': 'Quality of life measured by Quality of Life Questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'At 6 months', 'description': 'Quality of life measured by Quality of Life Questionnaire'}, {'measure': 'Self-esteem (Self-Esteem Questionnaire)', 'timeFrame': 'At 12 months', 'description': 'Self-esteem measured by Self-Esteem Questionnaire'}, {'measure': 'Self-esteem (Self-Esteem Questionnaire)', 'timeFrame': 'At 6 months', 'description': 'Self-esteem measured by Self-Esteem Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Problem', 'Low Weight', 'Short Stature']}, 'descriptionModule': {'briefSummary': "Study design:\n\nDouble 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.\n\nThe 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"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys aged ≥10years old\n* Prepubertal - Tanner stage 1 (gonadarche) (testicular volume\\<4)\n* Height and weight ≤ 10th percentile for age and gender.\n* Height-SDS ≥ -2.5 SDS\n* BMI-SDS\\>-3 SDS\n* Low proportion between weight and height\n* Signing inform consent forms\n\nExclusion Criteria:\n\n* Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH\n* 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\n* Any known gastrointestinal disease including malabsorption\n* Any known organic reason for growth retardation'}, 'identificationModule': {'nctId': 'NCT02389803', 'briefTitle': 'Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys', 'orgStudyIdInfo': {'id': 'rmc067614ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional supplementation standardized formula', '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 )', 'interventionNames': ['Dietary Supplement: Nutritional supplementation standardized formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'description': 'Low caloric formula (Powder added to water), without added vitamins and mineral', 'interventionNames': ['Dietary Supplement: Placebo comparator']}], 'interventions': [{'name': 'Nutritional supplementation standardized formula', 'type': 'DIETARY_SUPPLEMENT', 'description': '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 )', 'armGroupLabels': ['Nutritional supplementation standardized formula']}, {'name': 'Placebo comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low caloric formula (Powder added to water), without added vitamins and minerals', 'armGroupLabels': ['Placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Schneider Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Assaf Harofe Medical Center', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}], 'overallOfficials': [{'name': 'Moshe Phillip, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Schneider Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}