Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT05781620
Status:
UNKNOWN
Last Update Posted:
2023-12-19
First Post:
2023-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'A double-blind, matched-pair study design'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of NT-proBNP', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of NT-proBNP', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of NT-proBNP', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of NT-proBNP', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of cTnI', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of cTnI', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of cTnI', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of cTnI', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CK-MB', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CK-MB', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CK-MB', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CK-MB', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CK', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CK', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CK', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CK', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of Testosterone', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of Testosterone', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of Testosterone', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of Testosterone', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of Cortisol', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of Cortisol', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of Cortisol', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of Cortisol', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of β-endorphin', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of β-endorphin', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of β-endorphin', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of β-endorphin', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of Growth hormone', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of Growth hormone', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of Growth hormone', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of Growth hormone', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of IGF-1', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of IGF-1', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of IGF-1', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of IGF-1', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of TBARS', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of TBARS', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of TBARS', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of TBARS', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of PC', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of PC', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of PC', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of PC', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of SOD', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of SOD', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of SOD', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of SOD', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of Catalase', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of Catalase', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of Catalase', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of Catalase', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of TNF-α', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of TNF-α', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of TNF-α', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of TNF-α', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of IL-8', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of IL-8', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of IL-8', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of IL-8', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of IL-10', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of IL-10', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of IL-10', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of IL-10', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of LDH', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of LDH', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of LDH', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of LDH', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of IL-6', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of IL-6', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of IL-6', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of IL-6', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of IL-15', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of IL-15', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of IL-15', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of IL-15', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of leukocyte', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of leukocyte', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of leukocyte', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of leukocyte', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of neutrophil', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of neutrophil', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of neutrophil', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of neutrophil', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of eosinophil', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of eosinophil', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of eosinophil', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of eosinophil', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of basophil', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of basophil', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of basophil', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of basophil', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of monocyte', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of monocyte', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of monocyte', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of monocyte', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of lymphocyte', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of lymphocyte', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of lymphocyte', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of lymphocyte', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CD4+', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CD4+', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CD4+', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CD4+', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CD8+', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CD8+', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CD8+', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CD8+', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CD19+', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CD19+', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CD19+', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CD19+', 'timeFrame': '24-hour after exercise'}, {'measure': 'Concentration of CD56+', 'timeFrame': 'before exercise'}, {'measure': 'Concentration of CD56+', 'timeFrame': 'immediately after exercise'}, {'measure': 'Concentration of CD56+', 'timeFrame': '2-hour after exercise'}, {'measure': 'Concentration of CD56+', 'timeFrame': '24-hour after exercise'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of vitamin D supplementation on biochemistry response and skeletal muscle synthesis in prolonged endurance exercise.', 'detailedDescription': 'Endurance exercise mode will be used to evaluate the effects of vitamin D supplementation on cardiac biomarkers, metabolic hormones, oxidative damage, and inflammation responses. An independent samples and dose titration design will be used to assign 30 participants to the experimental group (n = 15) or placebo group (n = 15). All participants in the experimental group will have serum 25(OH)D concentrations higher than 48 ng/mL after supplementation period. After the prolonged endurance exercise test, the blood samples will be collected for analyzing biomarkers. Data will be analyzed by Two-way mixed design ANOVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* The volunteers included have conditions as stated below :\n\n 1. male adult between 20-40 years old without any history of cardiovascular, liver, kidney and diabetes disease\n 2. no acute sport injury\n 3. male adult whose concentration of 25(OH)D is under 30 ng/mL, and maximal oxygen consumption is over 40 ml/kg/min\n 4. did not participated in any clinical trials or research in the last 3 months before our experiment\n 5. no supplements were taken during the experimental period\n 6. were requested to maintain their regular daily life style and avoid alcohol intake\n\nExclusion Criteria:\n\n* The volunteers were excluded if they have the situation stated below:\n\n 1. history of cardiovascular, liver, kidney and diabetes disease\n 2. acute sport injury\n 3. their concentration of 25(OH)D is over 30 ng/mL, or maximal oxygen consumption is under 40 ml/kg/mint\n 4. participated in any clinical trials or experimental research in the last 3 months before our experiment\n 5. taking supplement during the experimental period\n 6. did not maintain their regular eating habit or drink alcohol'}, 'identificationModule': {'nctId': 'NCT05781620', 'briefTitle': 'Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effects of Vitamin D Supplementation on Biochemical Reaction and Skeletal Muscle Synthesis in Prolonged Endurance Exercise and Cluster Set Configurations of Resistance Training', 'orgStudyIdInfo': {'id': 'N202205045'}, 'secondaryIdInfos': [{'id': 'NSTC111-2410-H-038 -015', 'type': 'OTHER_GRANT', 'domain': 'National Science and Technology Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D group', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Dietary Supplement: Medium-chain triglycerides']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks. If the serum 25(OH)D concentration exceeds 48 ng/mL, the intervention remains the same. However, if the serum 25(OH)D concentration is under 48 ng/mL, the dosage would increase by 2,500 IU. The principle remains the same at week 6.', 'armGroupLabels': ['Vitamin D group']}, {'name': 'Medium-chain triglycerides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants received the same amount of placebo matching vitamin D orally twice daily.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Panion & BF Biotech Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}