Effect of Curcumin on Iron Metabolism in Healthy Volunteer (CURHEP)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Institut National de la Santé Et de la Recherche Médicale, France

ClinicalTrials.gov Identifier:

NCT01489592

First received: December 8, 2011

Last updated: April 10, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 8, 2011
Last Updated Date	April 10, 2013
Start Date ^ICMJE	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2011)	Maximal variation of serum hepcidin level after oral administration of curcumin [ Time Frame: within 48 hours after administration of curcumin ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01489592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 8, 2011)	Plasmatic iron bioavailability [ Time Frame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H ] [ Designated as safety issue: No ] Iron, ferritin, transferrin, transferrin saturation Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes [ Time Frame: 30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h ] [ Designated as safety issue: No ] In vitro: the coculture model that we previously developed to analyze endogenous hepcidin expression, and human hepatic cells line (HepG2) stimulated or not by IL-6 which governs the STAT3 pathway, transfected with gene reporter constructs containing hepcidin promoter.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Official Title ^ICMJE	Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers
Intervention ^ICMJE	Drug: curcuma longa oral administration of 6 grams of curcumin
Study Arm (s)	Experimental: curcumin oral administration of 6g of curcumin Intervention: Drug: curcuma longa Placebo Comparator: placebo oral administration of 12 sugar pill Intervention: Drug: curcuma longa
Publications *	Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Détivaud L, Leroyer P, Brissot P, Loréal 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. Epub 2010 Feb 19. Loréal 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. Review. 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. Epub 2006 Aug 31. 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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	March 2012
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Body mass index between 18 et 25 Kg/m² Non smoker No swallowing disorders Normal clinical exam Normal ECG Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides No C282Y mutation within the HFE gene Affiliation to social security Written informed consent obtained Exclusion Criteria: Chronic or evolutive disease Infection during the 7 days before each sequence Drug or alcohol (>30g) abuse Current treatment Known food allergy stay at altitude (> 1500m) in 2 months Positive serology for hepatitis B or C virus or HIV. Transfusion or blood donation during the last three months. Exclusion period on the healthy volunteer National File.
Gender	Male
Ages	18 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01489592
Other Study ID Numbers ^ICMJE	C11-14, 2011-001925-26
Has Data Monitoring Committee	No
Responsible Party	Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor ^ICMJE	Institut National de la Santé Et de la Recherche Médicale, France
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Institut National de la Santé Et de la Recherche Médicale, France
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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