Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 12:19 AM
Study NCT ID:
NCT00742768
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2008-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Absorption of Vitamin K2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D024482', 'term': 'Vitamin K 2'}], 'ancestors': [{'id': 'D014812', 'term': 'Vitamin K'}, {'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2008-08-27', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['absorption', 'encapsulation', 'menaquinone', 'Bio-availability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.\n\nThis study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women between 20 and 30 years old\n* Subjects of normal body weight and height according to BMI \\< 30\n* Subjects of Caucasian race\n* Subject has given written consent to take part in the study\n\nExclusion Criteria:\n\n* Subjects with (a history of) metabolic or gastrointestinal disease\n* Subjects presenting chronic degenerative and/or inflammatory disease\n* Subjects receiving corticoϊd treatment\n* Subjects using oral anticoagulants\n* Subject with (a history of) soy allergy\n* Subjects using vitamin K containing multivitamins or vitamin K supplements\n* Subjects with anaemia or subjects who recently donate blood.'}, 'identificationModule': {'nctId': 'NCT00742768', 'briefTitle': 'Comparison of Absorption of Vitamin K2', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Comparison of Absorption of Vitamin K2 Human Study Gelpell', 'orgStudyIdInfo': {'id': 'MEC 08-3-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'softgel capsules', 'interventionNames': ['Dietary Supplement: Vitamin K2 in softgel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Gelpell capsules', 'interventionNames': ['Dietary Supplement: Vitamin K2 in Gelpell']}], 'interventions': [{'name': 'Vitamin K2 in softgel', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule', 'armGroupLabels': ['1']}, {'name': 'Vitamin K2 in Gelpell', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'VitaK BV / Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Cees Vermeer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University, VitaK BV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'VitaK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}