Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-01 @ 5:39 PM
Study NCT ID:
NCT01489592
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C012596', 'term': 'turmeric extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-08', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal variation of serum hepcidin level after oral administration of curcumin', 'timeFrame': 'within 48 hours after administration of curcumin'}], 'secondaryOutcomes': [{'measure': 'Plasmatic iron bioavailability', 'timeFrame': '30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H', 'description': 'Iron, ferritin, transferrin, transferrin saturation'}, {'measure': "Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes", 'timeFrame': '30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h', 'description': 'In vitro:\n\n* the coculture model that we previously developed to analyze endogenous hepcidin expression, and\n* human hepatic cells line (HepG2) stimulated or not by IL-6 which governs the STAT3 pathway, transfected with gene reporter constructs containing hepcidin promoter.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '28370178', 'type': 'BACKGROUND', 'citation': 'Laine F, Laviolle B, Bardou-Jacquet E, Fatih N, Jezequel C, Collet N, Ropert M, Morcet J, Hamon C, Reymann JM, Loreal O. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study. Fundam Clin Pharmacol. 2017 Oct;31(5):567-573. doi: 10.1111/fcp.12288. Epub 2017 May 7.'}, {'pmid': '20169331', 'type': 'BACKGROUND', 'citation': 'Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Detivaud L, Leroyer P, Brissot P, Loreal O. Natural and synthetic STAT3 inhibitors reduce hepcidin expression in differentiated mouse hepatocytes expressing the active phosphorylated STAT3 form. J Mol Med (Berl). 2010 May;88(5):477-86. doi: 10.1007/s00109-009-0588-3. Epub 2010 Feb 19.'}, {'pmid': '15974953', 'type': 'BACKGROUND', 'citation': 'Loreal O, Haziza-Pigeon C, Troadec MB, Detivaud L, Turlin B, Courselaud B, Ilyin G, Brissot P. Hepcidin in iron metabolism. Curr Protein Pept Sci. 2005 Jun;6(3):279-91. doi: 10.2174/1389203054065392.'}, {'pmid': '16946298', 'type': 'BACKGROUND', 'citation': 'Verga Falzacappa MV, Vujic Spasic M, Kessler R, Stolte J, Hentze MW, Muckenthaler MU. STAT3 mediates hepatic hepcidin expression and its inflammatory stimulation. Blood. 2007 Jan 1;109(1):353-8. doi: 10.1182/blood-2006-07-033969. Epub 2006 Aug 31.'}, {'pmid': '15501961', 'type': 'BACKGROUND', 'citation': 'Sharma RA, Euden SA, Platton SL, Cooke DN, Shafayat A, Hewitt HR, Marczylo TH, Morgan B, Hemingway D, Plummer SM, Pirmohamed M, Gescher AJ, Steward WP. Phase I clinical trial of oral curcumin: biomarkers of systemic activity and compliance. Clin Cancer Res. 2004 Oct 15;10(20):6847-54. doi: 10.1158/1078-0432.CCR-04-0744.'}, {'pmid': '18559556', 'type': 'BACKGROUND', 'citation': 'Vareed SK, Kakarala M, Ruffin MT, Crowell JA, Normolle DP, Djuric Z, Brenner DE. Pharmacokinetics of curcumin conjugate metabolites in healthy human subjects. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1411-7. doi: 10.1158/1055-9965.EPI-07-2693.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 18 et 25 Kg/m²\n* Non smoker\n* No swallowing disorders\n* Normal clinical exam\n* Normal ECG\n* Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides\n* No C282Y mutation within the HFE gene\n* Affiliation to social security\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Chronic or evolutive disease\n* Infection during the 7 days before each sequence\n* Drug or alcohol (\\>30g) abuse\n* Current treatment\n* Known food allergy\n* stay at altitude (\\> 1500m) in 2 months\n* Positive serology for hepatitis B or C virus or HIV.\n* Transfusion or blood donation during the last three months.\n* Exclusion period on the healthy volunteer National File.'}, 'identificationModule': {'nctId': 'NCT01489592', 'acronym': 'CURHEP', 'briefTitle': 'Effect of Curcumin on Iron Metabolism in Healthy Volunteer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Effect of Curcumin on Iron Metabolism in Healthy Volunteer', 'orgStudyIdInfo': {'id': 'C11-14'}, 'secondaryIdInfos': [{'id': '2011-001925-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curcumin', 'description': 'oral administration of 6g of curcumin', 'interventionNames': ['Drug: curcuma longa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'oral administration of 12 sugar pill', 'interventionNames': ['Drug: curcuma longa']}], 'interventions': [{'name': 'curcuma longa', 'type': 'DRUG', 'description': 'oral administration of 6 grams of curcumin', 'armGroupLabels': ['curcumin', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': "Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}