Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
Study NCT ID:
NCT02099357
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2014-03-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'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': 'D003401', 'term': 'Creatine'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-01', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': '8 weeks'}, {'measure': 'Sum of 4 skinfold', 'timeFrame': '8 weeks', 'description': 'Triceps, Biceps, Subscapular and Iliac crest'}, {'measure': 'Corrected Arm Muscle Area', 'timeFrame': '8 weeks'}, {'measure': 'Seated Medicinal Ball Throw', 'timeFrame': '8 weeks'}, {'measure': 'Handgrip Strength with Hand Dynamometer', 'timeFrame': '8 weeks'}, {'measure': 'Manual Wheelchair Slalom Test', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of creatine monohydrate or vitamin D supplementation on strength gains following a traditional resistance training program for adults with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury\n* Minimum time since injury: 3 months\n\nExclusion Criteria:\n\n* Participation in resistance training programmes in the previous 6 months\n* Creatine or vitamin D supplementation in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT02099357', 'briefTitle': 'Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training', 'orgStudyIdInfo': {'id': 'FADEUPAFA20132015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine', 'description': 'Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks.', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation with 3g of monohydrate creatine during 8 weeks', 'armGroupLabels': ['Creatine']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D supplementation with 25000 IU each two weeks during eight weeks', 'armGroupLabels': ['Vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3064-908', 'city': 'Cantanhede', 'state': 'Coimbra District', 'country': 'Portugal', 'facility': 'Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais', 'geoPoint': {'lat': 40.34671, 'lon': -8.59419}}, {'zip': '4405-565', 'city': 'Vila Nova de Gaia', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Centro de Reabilitação do Norte', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}], 'overallOfficials': [{'name': 'Vitor H Teixeira, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto'}, {'name': 'Rui Corredeira, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculdade de Desporto, Universidade do Porto'}, {'name': 'Samuel Amorim, Bsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Desporto, Universidade do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bsc', 'investigatorFullName': 'Samuel Amorim', 'investigatorAffiliation': 'Universidade do Porto'}}}}