Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 5:44 AM
Study NCT ID:
NCT01594359
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Study of Effect of High Iron Beans on Iron Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved iron status', 'timeFrame': '1 year', 'description': 'Improvement in serum ferritin'}], 'secondaryOutcomes': [{'measure': 'Improved physical and cognitive performance', 'timeFrame': '1 year', 'description': 'Tests on physical performance using accelerometers and breath tests; cognitive tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ferritin'], 'conditions': ['Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '32006009', 'type': 'DERIVED', 'citation': "Luna SV, Pompano LM, Lung'aho M, Gahutu JB, Haas JD. Increased Iron Status during a Feeding Trial of Iron-Biofortified Beans Increases Physical Work Efficiency in Rwandan Women. J Nutr. 2020 May 1;150(5):1093-1099. doi: 10.1093/jn/nxaa016."}, {'pmid': '30926992', 'type': 'DERIVED', 'citation': 'Wenger MJ, Rhoten SE, Murray-Kolb LE, Scott SP, Boy E, Gahutu JB, Haas JD. Changes in Iron Status Are Related to Changes in Brain Activity and Behavior in Rwandan Female University Students: Results from a Randomized Controlled Efficacy Trial Involving Iron-Biofortified Beans. J Nutr. 2019 Apr 1;149(4):687-697. doi: 10.1093/jn/nxy265.'}, {'pmid': '28954841', 'type': 'DERIVED', 'citation': "Murray-Kolb LE, Wenger MJ, Scott SP, Rhoten SE, Lung'aho MG, Haas JD. Consumption of Iron-Biofortified Beans Positively Affects Cognitive Performance in 18- to 27-Year-Old Rwandan Female College Students in an 18-Week Randomized Controlled Efficacy Trial. J Nutr. 2017 Nov;147(11):2109-2117. doi: 10.3945/jn.117.255356. Epub 2017 Sep 27."}, {'pmid': '27358417', 'type': 'DERIVED', 'citation': "Haas JD, Luna SV, Lung'aho MG, Wenger MJ, Murray-Kolb LE, Beebe S, Gahutu JB, Egli IM. Consuming Iron Biofortified Beans Increases Iron Status in Rwandan Women after 128 Days in a Randomized Controlled Feeding Trial. J Nutr. 2016 Aug;146(8):1586-92. doi: 10.3945/jn.115.224741. Epub 2016 Jun 29."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.', 'detailedDescription': 'The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study\n\nExclusion Criteria:\n\n* Pregnant, lactating, severe anemia, low BMI would be excluded'}, 'identificationModule': {'nctId': 'NCT01594359', 'briefTitle': 'Nutrition Study of Effect of High Iron Beans on Iron Status', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Project #8209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High iron bean', 'description': 'High-iron bean', 'interventionNames': ['Other: Biofortified beans']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low iron bean', 'description': 'Low-iron bean', 'interventionNames': ['Other: BEAN']}], 'interventions': [{'name': 'Biofortified beans', 'type': 'OTHER', 'description': 'Comparison of two types of the common bean that are similar in all aspects except their iron concentration - one has a high iron concentration while the other has low iron concentration', 'armGroupLabels': ['High iron bean']}, {'name': 'BEAN', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Low iron bean']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Butare', 'state': 'Kigali', 'country': 'Rwanda', 'facility': 'National University of Rwanda', 'geoPoint': {'lat': -1.859, 'lon': 30.1304}}, {'city': 'Kigali', 'state': 'Kigali', 'country': 'Rwanda', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}], 'overallOfficials': [{'name': 'Richard F. Hurrell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'HarvestPlus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Prof. Michael B. Zimmermann', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}