Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: curcuma longa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: curcumin
oral administration of 6g of curcumin
Drug: curcuma longa
oral administration of 6 grams of curcumin
Placebo Comparator: placebo
oral administration of 12 sugar pill
Drug: curcuma longa
oral administration of 6 grams of curcumin

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489592

Locations
France
Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou
Rennes, France, 35000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01489592     History of Changes
Other Study ID Numbers: C11-14, 2011-001925-26
Study First Received: December 8, 2011
Last Updated: April 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Curcumin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014