Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02400151
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Flow Mediated Dilation (%) at the brachial artery', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Nitrate Mediated Dilation (%) at the brachial artery', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in carotid compliance (mm^2mmHg^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in brachial compliance (mm^2mmHg^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in arterial wave speed (m*s^-1)', 'timeFrame': '3 months'}, {'measure': 'Usual Vitamin D intake according to food questionnaire', 'timeFrame': 'Baseline'}, {'measure': 'Change from baseline in blood 25(OH)D levels (mmol*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in blood parathyroid hormone levels (mmol*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in serum calcium levels (mmol*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in blood total protein levels (g*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Homeostatic model assessment Insulin Resistance', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in the ratio Low Density Lipoprotein/High Density Lipoprotein', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Triglyceride levels', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Acetylcholine-Cutaneous Blood Flow peak', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Sodium nitroprussiate-Cutaneous Blood Flow peak (%)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Insulin-Cutaneous Blood Flow peak (%)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in TNF-alpha (pg*mL^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in IL-6 (pg*mL^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in High sensitivity C-reactive protein (pg*mL^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in leptin (pg*mL^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in adiponectin (pg*mL^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in SuperOxyde Dismutase (U*gHb^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Isoprostanes (ng*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in nitrite-nitrate (µmol*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in PAI-1 (µmol*L^-1)', 'timeFrame': '3 months'}, {'measure': 'Metabolomic profile', 'timeFrame': 'baseline'}, {'measure': 'Metabolomic profile', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '34090775', 'type': 'RESULT', 'citation': 'Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).', 'detailedDescription': 'The secondary objectives of this study are:\n\nA. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation on metabolic and vascular function.\n\nB. To compare the relationships between food intake, metabolic, inflammatory, oxidative stress and vitamin D status, and vascular dysfunction between obese and normal weight subjects.\n\nC. To evaluate the effects of sun exposure variations on relationships described in Objective B by comparing the observed parameters at baseline and at the end of the three month follow-up period, in non-supplemented obese adolescents and adolescents of normal weight.\n\nD. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin D deficiency and vascular function.\n\nE. To evaluate in obese adolescents, the effects of vitamin D supplementation on the metabolome (metabolic signature).\n\nF. To evaluate the effects of lifestyle and dietary management on these biomarkers (in the "control group").\n\nFor these targets (A to F), all teenagers will be classified according to three levels of skin pigmentation.\n\nG. Establish a biobank of samples taken at baseline and at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "General Inclusion Criteria:\n\n* The patient's legal representatives must have given their informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* Sexual maturation of at least Tanner stage 2\n\nInclusion criteria for the patient population\n\n* The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)\n* Absence of at least 5% of total weight over the last 3 months\n\nInclusion criteria for the control population\n\n* The subject has a body mass index \\< 90th percentile\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection\n* The patient's legal representative(s) refuse(s) to sign the consent\n* It is impossible to correctly inform the patient or his/her legal representative(s)\n* The patient has a contraindication for physical activity (joint, heart or other)\n* The subject does at least 3 hours of extracurricular physical activity per week\n* The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).\n* Active smoking\n* Known dyslipidemia (particularly hypercholesterolemia).\n* The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).\n* BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.\n* Secondary or known genetic obesity.\n* Known hypersensitivity to vitamin D.\n* Hypercalcemia, hypercalciuria, calcium lithiasis"}, 'identificationModule': {'nctId': 'NCT02400151', 'acronym': 'VIDADO', 'briefTitle': 'Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'LOCAL/2015/APM-01'}, 'secondaryIdInfos': [{'id': '2015-000060-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-Obese group', 'description': 'Non-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation.\n\nIntervention: Normal control', 'interventionNames': ['Other: Normal control']}, {'type': 'EXPERIMENTAL', 'label': 'Obese group, Vitamin D', 'description': 'Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.\n\nIntervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation', 'interventionNames': ['Drug: Vitamin D supplementation', 'Other: 3 months lifestyle and dietary management']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Obese group, placebo', 'description': 'Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.\n\nIntervention: 3 months lifestyle and dietary management Intervention: Placebo', 'interventionNames': ['Drug: Placebo', 'Other: 3 months lifestyle and dietary management']}], 'interventions': [{'name': 'Vitamin D supplementation', 'type': 'DRUG', 'description': 'Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.', 'armGroupLabels': ['Obese group, Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients randomized to this group will receive placebo for 90 days.', 'armGroupLabels': ['Obese group, placebo']}, {'name': '3 months lifestyle and dietary management', 'type': 'OTHER', 'description': 'Lifestyle and dietary management at the Saint Pierre Institute (Palavas-les-Flots, France) occurs for three months. Nutritionally speaking, each child or adolescent receives a controlled and balanced diet, consistent with the recommendations appropriate for his/her age, slightly hypocaloric or normocaloric. This dietary approach is complemented by a nutrition education program and supervision by a doctor and a dietician. Three hours of exercise training per week are scheduled; these sessions include adapted aerobic activities supervised by instructors and educators at the center.', 'armGroupLabels': ['Obese group, Vitamin D', 'Obese group, placebo']}, {'name': 'Normal control', 'type': 'OTHER', 'description': 'Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.', 'armGroupLabels': ['Non-Obese group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '34250', 'city': 'Palavas-les-Flots', 'country': 'France', 'facility': 'Institut Saint Pierre', 'geoPoint': {'lat': 43.52974, 'lon': 3.93043}}], 'overallOfficials': [{'name': 'Antonia Perez Martin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMR1260 NORT Nutrition, Obésité et Risque Thrombotique', 'class': 'UNKNOWN'}, {'name': 'EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}