Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00459732
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2007-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zinc & Bone Health in Thalassemia: The Think Zinc Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}, {'id': 'D019287', 'term': 'Zinc Sulfate'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D017967', 'term': 'Zinc Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'efung@mail.cho.org', 'phone': '510-428-3885', 'title': 'Ellen Fung, PhD RD CCD', 'phoneExt': '4939', 'organization': "Children's Hospital & Research Center, Oakland"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Recorded between baseline and 18 month time point (end of study)', 'description': 'Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.', 'eventGroups': [{'id': 'EG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily', 'otherNumAtRisk': 19, 'otherNumAffected': 17, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group', 'otherNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Upset', 'notes': 'Includes general stomach upset and/or cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Fatigue that is different that usual pre-transfusion fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'One subject on the placebo arm of the trial died from cardiomyopathy secondary to iron overload after the 12 month time point.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 18 months', 'description': 'Change in pa spine bone mineral density by DXA between baseline and 18 months', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).'}, {'type': 'PRIMARY', 'title': 'Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 18 months', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)'}, {'type': 'SECONDARY', 'title': 'Osteocalcin, a Marker of Bone Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '23.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Repeated measures analysis of variance adjusted for baseline osteocalcin level.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 18 months', 'description': 'Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '4 on zn dropped: 1 pregnant and 1 nausea after baseline, 1 lost to followup, 1 exited after 12 month', 'groupId': 'FG000', 'numSubjects': '19'}, {'comment': '3 on placebo dropped: 1 pregnant after 12 mo, 1 lost to followup, one died after 12 month timepoint', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 3 hematology clinics in the US between April, 2006 and May, 2008. 114 potentially eligible patients were screened, 43 were considered eligible and consented to participation.', 'preAssignmentDetails': 'Following enrollment, prior to group assignment, subjects were screened for copper and vitamin D status. If serum copper was \\<70ug/dL and/or 25OH vitamin D \\<20ng/mL, they were placed on daily supplementation, 2 mg Cu/day and/or 1000 IU vitamin D/day.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zinc', 'description': '25 mg of zinc as zn sulfate taken daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'daily capsule similar in size/color to zn was taken daily by this group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '17.4', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Plasma Zinc', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '11', 'groupId': 'BG000'}, {'value': '79', 'spread': '14', 'groupId': 'BG001'}, {'value': '78', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Concentration of zinc within the plasma at baseline, mcg/dL', 'unitOfMeasure': 'mcg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spine Z-score', 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '-2.4', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '-2.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Spine standard deviation score (Z-score) determined by baseline DXA bone density scan', 'unitOfMeasure': 'Z-score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2007-04-11', 'resultsFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2007-04-11', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-25', 'studyFirstPostDateStruct': {'date': '2007-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)', 'timeFrame': '0 to 18 months', 'description': 'Change in pa spine bone mineral density by DXA between baseline and 18 months'}, {'measure': 'Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)', 'timeFrame': 'Baseline to 18 months'}], 'secondaryOutcomes': [{'measure': 'Osteocalcin, a Marker of Bone Formation', 'timeFrame': 'Baseline to 18 months', 'description': 'Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['zinc, thalassemia, bone mineral density'], 'conditions': ['Thalassemia']}, 'referencesModule': {'references': [{'pmid': '23945720', 'type': 'DERIVED', 'citation': 'Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.', 'detailedDescription': 'The primary aim of this study is to determine if zinc supplementation improves bone health in young patients with thalassemia. Osteoporosis is a significant co-morbidity in patients with thalassemia which leads to decreased quality of life. The most effective way to prevent osteoporosis is to build strong, dense bones in the early years. A combination of disease, endocrine and nutritional factors likely contribute to the etiology of osteoporosis in this population. However, even well transfused patients with normal gonadal function who are supplemented with calcium have low bone mass. It is hypothesized that patients with thalassemia have low bone mass, in part, due to zinc deficiency. Sub-optimal zinc status has been identified in patients with thalassemia and zinc supplementation has been shown to improve linear growth. To test the primary hypothesis, an 18 month randomized placebo-controlled trial of zinc supplementation (25 mg Zn/day) vs. placebo will be conducted in 60 young patients (6-30 yrs) with thalassemia and low bone mass (spine BMD Z-score \\<-1.0). Bone health, as estimated from measurements of bone mass (by DXA and pQCT) and markers of bone formation and resorption will be the primary outcome variables. This will be the first study to examine the effects of zinc. supplementation on bone health in patients with thalassemia. If zinc supplementation is found to have a clinically important effect, this simple, safe, non-invasive therapy could quickly become a part of the standard care of these young patients and improve overall health in children and adult patients with thalassemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 to 30 years of age\n* thalassemia\n* bone mineral density Z-score \\< -1.0 (by DXA)\n\nExclusion Criteria:\n\n* Bone marrow transplant recipient\n* Currently prescribed treatment for low bone mass other than calcium or vitamin D (e.g. calcitonin, bisphosphonates)\n* Currently prescribed zinc supplementation who are unable or unwilling to stop during this trial\n* Currently participating in another trial with a medication known to affect bone mineral density.\n* Chronic use of systemic corticosteroids\n* Untreated hypogonadism or growth hormone deficiency\n* Baseline serum copper \\< 70 µg/dL\n* Baseline vitamin D-25OH \\< 11 ng/mL\n* Pregnant or lactating at study entry'}, 'identificationModule': {'nctId': 'NCT00459732', 'acronym': 'ThinkZn', 'briefTitle': 'Zinc & Bone Health in Thalassemia: The Think Zinc Study', 'nctIdAliases': ['NCT00480415'], 'organization': {'class': 'OTHER', 'fullName': "UCSF Benioff Children's Hospital Oakland"}, 'officialTitle': 'Zinc and Bone Metabolism in Thalassemia', 'orgStudyIdInfo': {'id': '2004-106'}, 'secondaryIdInfos': [{'id': 'K23HL076468', 'link': 'https://reporter.nih.gov/quickSearch/K23HL076468', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Capsule', 'description': 'placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zinc (25 mg/d)', 'description': '25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months', 'interventionNames': ['Dietary Supplement: Zinc']}], 'interventions': [{'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['zinc sulphate', 'elemental zinc'], 'description': '25 mg of elemental zinc as zinc sulphate take once daily for 18 months', 'armGroupLabels': ['Zinc (25 mg/d)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['"sugar" pill'], 'description': 'Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months', 'armGroupLabels': ['Placebo Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital & Research Center, Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ellen B. Fung, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}