Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT04623918
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2020-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron-Biofortified Rice Intervention in the Philippines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking description: The study was a double-blind, randomized controlled trial of; (1) iron-biofortified rice (IR68144-2B-2-2-3), compared to (2) a commercially available variety of rice (C4), with the intervention randomized at the individual level. Administrators, participants, research staff (i.e. responsible for daily data collection and preparation of rice for all meals, assessment of outcomes), and laboratory staff were blinded to the intervention group.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2003-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2003-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum ferritin', 'timeFrame': '9 months', 'description': 'Serum ferritin (SF)'}, {'measure': 'Change in sTfR', 'timeFrame': '9 months', 'description': 'Soluble transferrin receptor (sTfR)'}, {'measure': 'Change in TBI', 'timeFrame': '9 months', 'description': 'Total body iron (TBI)'}], 'secondaryOutcomes': [{'measure': 'Change in hemoglobin among women who were anemic at baseline', 'timeFrame': '9 months', 'description': 'Changes in hemoglobin (Hb) in women who were anemic at baseline'}, {'measure': 'Changes in SF among women who were non-anemic at baseline', 'timeFrame': '9 months', 'description': 'Changes in SF among women who were non-anemic at baseline'}, {'measure': 'Changes in sTfR among women who were non-anemic at baseline', 'timeFrame': '9 months', 'description': 'Changes in sTfR among women who were non-anemic at baseline'}, {'measure': 'Changes in TBI among women who were non-anemic at baseline', 'timeFrame': '9 months', 'description': 'Changes in TBI among women who were non-anemic at baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Iron', 'Biofortification', 'Philippines', 'Iron deficiency', 'Women of reproductive age'], 'conditions': ['Iron-deficiency', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '16317127', 'type': 'BACKGROUND', 'citation': 'Haas JD, Beard JL, Murray-Kolb LE, del Mundo AM, Felix A, Gregorio GB. Iron-biofortified rice improves the iron stores of nonanemic Filipino women. J Nutr. 2005 Dec;135(12):2823-30. doi: 10.1093/jn/135.12.2823.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.', 'detailedDescription': 'Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.\n\nThe investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.\n\nThe objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.\n\nThe long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women (18-45 years old) living in convents in the greater Manila area\n* Hb ≥10.5 g/dL\n\nExclusion Criteria:\n\n* Current or history of gastrointestinal or hematological disorders\n* Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption\n* Hb \\<10.5 g/dL\n* Women expressed uncertainty in their ability to participate for the full (9 month) trial'}, 'identificationModule': {'nctId': 'NCT04623918', 'briefTitle': 'Iron-Biofortified Rice Intervention in the Philippines', 'organization': {'class': 'OTHER', 'fullName': 'Cornell University'}, 'officialTitle': 'Randomized Trial of Iron-Biofortified Rice in Women in the Philippines', 'orgStudyIdInfo': {'id': 'Haas2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron-biofortified rice', 'description': 'Iron-biofortified rice (IR68144-2B-2-2-3)', 'interventionNames': ['Other: Iron-biofortified rice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control rice', 'description': 'Control rice (C4)', 'interventionNames': ['Other: Control rice']}], 'interventions': [{'name': 'Iron-biofortified rice', 'type': 'OTHER', 'description': 'Iron-biofortified rice (IR68144-2B-2-2-3)', 'armGroupLabels': ['Iron-biofortified rice']}, {'name': 'Control rice', 'type': 'OTHER', 'description': 'Control rice (C4), identical in appearance', 'armGroupLabels': ['Control rice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Los Baños', 'state': 'Laguna', 'country': 'Philippines', 'facility': 'University of the Philippines', 'geoPoint': {'lat': 14.17025, 'lon': 121.24181}}], 'overallOfficials': [{'name': 'Jere Haas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}, {'name': 'University of the Philippines', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}