Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-22 @ 4:01 AM
Study NCT ID:
NCT02292303
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015034', 'term': 'Zinc Oxide'}, {'id': 'C030691', 'term': 'gluconic acid'}], 'ancestors': [{'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.', 'timeFrame': 'Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min'}], 'secondaryOutcomes': [{'measure': 'Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.', 'timeFrame': 'Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Zinc/pharmacokinetics'], 'conditions': ['Zinc Deficiency']}, 'descriptionModule': {'briefSummary': 'The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations\n* Sex: female (premenopausal), male\n* Age: 20 - 50 years\n* BMI ≥19 or ≤30 kg/m²\n* Non-smoker\n* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology\n\nExclusion Criteria:\n\n* Relevant history or presence of any medical disorder, potentially interfering with this trial\n* For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening\n* Migraine or regular headache, intense premenstrual symptoms\n* Coffee consumption \\>3 cups / day\n* Blood donation within 2 months prior to trial start or during trial\n* Regular intake of mineral supplements within 4 weeks prior to trial start or during trial\n* Chronic intake of substances affecting the intestinal absorption of zinc\n* Vegetarians / vegans\n* Drug-, alcohol- and medication abuses\n* Known HIV-infection\n* Known acute or chronic hepatitis B and C infection\n* Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance\n* Known pregnancy, breast feeding or intention to become pregnant during the study\n* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial\n* Not anticipating any planned changes in lifestyle for the duration of the study'}, 'identificationModule': {'nctId': 'NCT02292303', 'briefTitle': 'Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lesaffre International'}, 'officialTitle': 'Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations', 'orgStudyIdInfo': {'id': 'BTS812/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zinc-enriched yeast', 'description': 'zinc-enriched yeast capsules', 'interventionNames': ['Dietary Supplement: zinc-enriched yeast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'zinc oxide', 'description': 'zinc oxide capsules', 'interventionNames': ['Dietary Supplement: Zinc references']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'zinc gluconate', 'description': 'zinc gluconate capsules', 'interventionNames': ['Dietary Supplement: Zinc references']}], 'interventions': [{'name': 'zinc-enriched yeast', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['zinc-enriched yeast']}, {'name': 'Zinc references', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['zinc oxide; zinc gluconate'], 'armGroupLabels': ['zinc gluconate', 'zinc oxide']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lesaffre International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}