Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 2:00 PM
Study NCT ID:
NCT01633450
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2012-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc Absorption From Biofortified Rice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional absorption of zinc', 'timeFrame': '33 days', 'description': 'Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26674764', 'type': 'DERIVED', 'citation': 'Brnic M, Wegmuller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of 18 to 45 years old\n* Body Mass Index in the range of 19 to 25\n* No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study\n\nExclusion Criteria:\n\n* Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)\n* Long-term medication during the whole study (except for contraceptives)\n* Pregnancy\n* Lactation\n* Intention to become pregnant during the course of the study\n* Lack of safe contraception\n* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study'}, 'identificationModule': {'nctId': 'NCT01633450', 'briefTitle': 'Zinc Absorption From Biofortified Rice', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study', 'orgStudyIdInfo': {'id': 'HNL/CTC12-Reis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc biofortified rice', 'interventionNames': ['Other: Zinc biofortified rice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rice extrinsically fortified with zinc', 'interventionNames': ['Other: Rice extrinsically fortified with zinc']}], 'interventions': [{'name': 'Zinc biofortified rice', 'type': 'OTHER', 'description': '1.12 mg zinc per meal', 'armGroupLabels': ['Zinc biofortified rice']}, {'name': 'Rice extrinsically fortified with zinc', 'type': 'OTHER', 'description': '1.12 mg zinc per meal', 'armGroupLabels': ['Rice extrinsically fortified with zinc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Prof. Michael B. Zimmermann', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}