Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-03 @ 11:37 AM
Study NCT ID:
NCT03810261
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vitamin D serum concentration after 8 weeks of supplementation', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.\n\nA randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.\n\nStudy subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vitamin D suboptimal status\n* Signed Informed consent form (ICF),\n* Caucasian race\n* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),\n* Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources\n* Willingness to follow all study procedures\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding,\n* Known or suspected allergy to any ingredient of the tested products in Part 2,\n* Pronounced avoidance of sunshine (eg reporting of allergy to the sun)\n* Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,\n* Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded)\n* Diets prescribed by the medical profession\n* Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases\n* Other diseases and conditions that affect the absorption and synthesis of vitamin D\n* Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),\n* The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,\n* Visiting the solarium in the last three months before joining the survey,\n* Mental incapacity that precludes adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT03810261', 'acronym': 'VITAD/2', 'briefTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2', 'orgStudyIdInfo': {'id': 'VITAD-01-2018 Part 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oil-based vitamin D group', 'description': 'Oil-based vitamin D, 1000 IU/day for 8 weeks', 'interventionNames': ['Dietary Supplement: Oil-based vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Water-based vitamin D group', 'description': 'Water-based vitamin D, 1000 IU/day for 8 weeks', 'interventionNames': ['Dietary Supplement: Water-based vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D capsules group', 'description': 'Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks', 'interventionNames': ['Dietary Supplement: Vitamin D capsules']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will receive no intervention.'}], 'interventions': [{'name': 'Oil-based vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.', 'armGroupLabels': ['Oil-based vitamin D group']}, {'name': 'Water-based vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.', 'armGroupLabels': ['Water-based vitamin D group']}, {'name': 'Vitamin D capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.', 'armGroupLabels': ['Vitamin D capsules group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Nutrition Institute, Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Katja Žmitek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'VIST - Faculty of Applied Sciences', 'class': 'OTHER'}, {'name': 'Slovenian Research Agency', 'class': 'OTHER'}, {'name': 'Valens Int. d.o.o., Slovenija', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}