Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01323218
Status:
UNKNOWN
Last Update Posted:
2011-03-25
First Post:
2011-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Apnea Syndrome and Vitamin D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-24', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}], 'secondaryOutcomes': [{'measure': 'Epworth sleepiness scale', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2)', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'Continuous positive airway pressure measured with a CPAP equipment', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'Muscular strength measured with handgrip test', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)', 'timeFrame': 'at the beginning (day 0) and after 32 days of vitamin D supplementation'}, {'measure': 'Analysis of genes implicated in vitamin D metabolism', 'timeFrame': 'at inclusion.'}]}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea-hypopnea syndrome', 'OSAHS', 'Vitamin D'], 'conditions': ['Obstructive Sleep Apnea-hypopnea Syndrome']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.\n\nOSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.\n\nA normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.', 'detailedDescription': 'Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D.\n\nAfter written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe obstructive sleep apnoea (AHI \\> 15)\n* With or without continuous positive airway pressure for a minimum of six months\n* aged 30-75 years\n* Vitamin D2D3 level \\< 30 ng/ml\n\nExclusion Criteria:\n\n* Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism\n* Patients with mixed sleep apnoea (central and obstructive)\n* Patients with CPAP use \\< 4 hours per night\n* Patients with maxillofacial or oro-pharyngeal diseases)\n* Patients with chronic respiratory failure, hypercapnic patients\n* Muscle diseases\n* Alcohol intake \\> 2 glasses per day\n* Body mass index \\> 40 kg/m2'}, 'identificationModule': {'nctId': 'NCT01323218', 'briefTitle': 'Sleep Apnea Syndrome and Vitamin D', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)', 'orgStudyIdInfo': {'id': 'CHU-0091'}}, 'armsInterventionsModule': {'interventions': [{'name': '25 OH vitamin D', 'type': 'DRUG', 'description': 'After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}, {'name': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe', 'class': 'OTHER'}, {'name': 'Laboratoire Crinex', 'class': 'UNKNOWN'}, {'name': 'Laboratoire Cidelec', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Patrick LACARIN', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}