Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 1:52 PM
Study NCT ID:
NCT02621320
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Wheelchair Indoor Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'week 0, 1 day before they start supplementation', 'description': 'Peak heart rate measured during wingate test'}, {'measure': 'Heart rate', 'timeFrame': '12 weeks post supplementation', 'description': 'Peak heart rate measured during wingate test'}, {'measure': 'blood lactate concentration', 'timeFrame': 'week 0, 1 day before they start supplementation', 'description': 'before, during and after wingate test'}, {'measure': 'blood lactate concentration', 'timeFrame': '12 weeks post supplementation', 'description': 'before, during and after wingate test'}], 'primaryOutcomes': [{'measure': 'peak power', 'timeFrame': 'delta change from pre to 12 weeks post supplementation', 'description': 'peak power measured during wingate test'}, {'measure': 'maximum torque', 'timeFrame': 'delta change from pre to 12 weeks post supplementation', 'description': 'maximum torque measured with dynamometer'}], 'secondaryOutcomes': [{'measure': 'Vitamin D serum level', 'timeFrame': 'week 0, 1 day before they start supplementation', 'description': 'measured with venous blood sample'}, {'measure': 'Vitamin D serum level', 'timeFrame': '12 weeks post supplementation', 'description': 'measured with venous blood sample'}, {'measure': 'Count of injuries', 'timeFrame': '12 weeks post supplementation', 'description': 'DASH questionaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Exercise Performance', 'Wheelchair Athletes', 'Indoor sports', 'Wingate', 'Isokinetic Dynamometer'], 'conditions': ['Vitamin D Deficiency', 'Spinal Cord Injury', 'Drug Effects', 'Dietary Supplements', 'Physical Education and Training/Methods']}, 'descriptionModule': {'briefSummary': 'There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well as wheelchair users, vitamin D deficiency occurs even more often. It is well established that vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in individuals with a vitamin D deficiency has a positive effect on muscle performance. In recently published studies with able-bodied subjects, it has been shown that a normal vitamin D level (\\>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.\n\nThe aim of this study is to examine the effect of vitamin D supplementation on exercise performance in wheelchair athletes with vitamin D deficiency . All participants with a vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D level will receive placebo treatment (control group). The physical performance is measured three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and a dynamometer test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* swiss elite wheelchair athlete\n* 18 to 60 years\n* male, healthy\n* at least 2x45min sports a week\n\nExclusion Criteria:\n\n* participation in another study\n* medication which influences performance\n* respiratory and cardiovascular disease\n* daily intake of \\>400IU Vitamin D\n* parathyroid gland disease\n* kidney insufficiency\n* visit abroad below the 37th parallel latitude during study or shortly before'}, 'identificationModule': {'nctId': 'NCT02621320', 'acronym': 'VitD_SCI', 'briefTitle': 'Vitamin D Supplementation in Wheelchair Indoor Athletes', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Effect of Vitamin D3 Supplementation on Exercise Performance in Wheelchair Athletes.', 'orgStudyIdInfo': {'id': '2015-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day.', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'alcohol-based solution 1.3ml daily over a period of 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}