Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01462058
Status:
COMPLETED
Last Update Posted:
2012-03-29
First Post:
2011-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016574', 'term': 'Seasonal Affective Disorder'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2011-10-26', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton-29', 'timeFrame': '12 weeks', 'description': 'Change from baseline in Hamilton-29 at week 12'}], 'secondaryOutcomes': [{'measure': 'WHO-5', 'timeFrame': '12 weeks', 'description': 'Change from baseline in WHO-5 at week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SPAQ', 'Sigh-SAD', 'Hamilton 29', 'Vitamin D3', 'p25(OH)D'], 'conditions': ['Seasonal Affective Disorder', 'Vitamin D3', 'Mental Health', 'Dietary Supplement']}, 'referencesModule': {'references': [{'pmid': '25125215', 'type': 'DERIVED', 'citation': 'Frandsen TB, Pareek M, Hansen JP, Nielsen CT. Vitamin D supplementation for treatment of seasonal affective symptoms in healthcare professionals: a double-blind randomised placebo-controlled trial. BMC Res Notes. 2014 Aug 14;7:528. doi: 10.1186/1756-0500-7-528.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care', 'detailedDescription': 'Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D \\[25(OH)D\\], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D \\[1,25(OH)2D\\].\n\nAt higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of \\[25(OH)D\\] in the blood and especially in the early spring months the levels of \\[25(OH)D\\] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.\n\nNew research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.\n\nIn clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.\n\nThe objective of this randomized clinical trial is to investigate whether indoor employees, with tendency to depressive symptoms in the winter season, should be offered vitamin D3 supplements during the Winter season, or it has no significance in relation prevent depressive symptoms.\n\nThe study is carried out in the winter season in the Region of Southern Denmark for 12 weeks and offered to health service staff, who have a tendency for depressive symptoms in the winter season.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health service staff and employee in the Region of Southern Denmark.\n* Tendency to depressive symptoms in the winter season SPAQ\\>7.\n\nExclusion Criteria:\n\n* clinical diagnosis sarcoidoses\n* tuberculosis\n* bipolar affective disorder\n* schizophrenia\n* hypercalcemia\n* hyperphosphatemia\n* pregnancy\n* hyperparathyroidism\n* reduced kidney function'}, 'identificationModule': {'nctId': 'NCT01462058', 'acronym': 'D3-vit-SAD', 'briefTitle': 'The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff', 'organization': {'class': 'OTHER', 'fullName': 'Region Syddanmark'}, 'orgStudyIdInfo': {'id': 'ID-301115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D3', 'description': 'one tablet of vitamin D3 (70µg) per day for 12 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'one tablet of sugar pill per day for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Active'], 'description': '70µg Vitamin D3, daily, 12 weeks', 'armGroupLabels': ['Vitamin D3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, daily, 12 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6715', 'city': 'Esbjerg', 'state': 'Esbjerg N', 'country': 'Denmark', 'facility': 'Mental Health Services Esbjerg', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Connie Thuree Nielsen, consultant, MD, ph.d', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, ph.d', 'investigatorFullName': 'Connie Thuree Nielsen, consultant, MD, ph.d', 'investigatorAffiliation': 'Region Syddanmark'}}}}