Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03990181
Other study ID # FePPHH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2019
Est. completion date August 15, 2020

Study information

Verified date May 2021
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory pathway, leading to excess iron in the body. This study investigates the inhibitory effect of a natural polyphenol Supplement in participants with HH.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date August 15, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Homozygous for C282Y mutation in HFE (hemochromatosis) gene - Written informed consent - Age 18-65 y - Not pregnant or lactating - Body weight < 75 kg - Body mass index (BMI) between 18.5 and 25 kg/m2 - No acute illness/infection (self-reported) - No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported) - No scheduled phlebotomy throughout the study period - The last phlebotomy will be at least 4 weeks prior first test meal administration - No use of medications affecting iron absorption or metabolism during the study - No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study - Participation in any other clinical study within the last 30 days - Expected to comply with study protocol

Study Design


Intervention

Dietary Supplement:
meal matrix & NPPS
Test meal consumed with the natural polyphenol supplement
meal matrix & CS
Test meal consumed with the control supplement
no-matrix & NPPS
Test drink consumed with the natural polyphenol supplement
no-matrix & CS
Test drink consumed with the control supplement

Locations

Country Name City State
Portugal Porto University Hospital Center Porto
Switzerland Laboratory of Human Nutrition ETH Zurich Zurich

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Instituto de Investigação em Imunologia

Countries where clinical trial is conducted

Portugal,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in the isotopic ratio of iron in blood at week 2 The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes baseline, 2 weeks
Primary change from baseline in the isotopic ratio of iron in blood at week 4 The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes 2 weeks, 4 weeks
Secondary Serum Ferritin concentration (µg/L) to assess iron status baseline, weeks 2, and 4
Secondary Serum iron concentration (µg/dL) to assess iron status baseline, weeks 2, and 4
Secondary Soluble transferrin receptor (mg/L) to assess iron status baseline, weeks 2, and 4
Secondary Transferrin saturation in % to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio) baseline, weeks 2, and 4
Secondary Hemoglobin (g/dL) to assess blood volume based on weight, height, and Hb. baseline, weeks 2, and 4
Secondary C-reactive Protein (mg/L) identify acute inflammation baseline, weeks 2, and 4
Secondary alpha-1-glycoprotein (g/L) identify chronic inflammation baseline, weeks 2, and 4
Secondary Serum Hepcidin (nM) the major regulator of non-heme iron absorption baseline, and weeks 2
See also
  Status Clinical Trial Phase
Recruiting NCT04423237 - Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT
Completed NCT04614779 - Long-term Clinical Study of CN128 in Thalassemia Patients Phase 2
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT02833493 - Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload N/A
Completed NCT02164253 - Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients Phase 2
Completed NCT00901199 - Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload Phase 2
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Recruiting NCT00378469 - Study of the Effects of Muscular Activity on Iron Metabolism N/A
Completed NCT00117507 - Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients Phase 4
Completed NCT00138684 - Cytochrome P450 2E1 and Iron Overload Phase 2
Terminated NCT02274233 - Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia Phase 1
Active, not recruiting NCT01443195 - Iron Metabolism in Small Pre Term Newborns N/A
Completed NCT01546415 - Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia Phase 4
Completed NCT01572818 - Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients N/A
Not yet recruiting NCT00980421 - Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children Phase 3
Completed NCT01047098 - Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation N/A
Recruiting NCT05294471 - Fully Automated High-Throughput Quantitative MRI of the Liver
Completed NCT03591575 - Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children Phase 4
Active, not recruiting NCT00907283 - Ferrochelating Treatment in Patients Affected by Neurodegeneration With Brain Iron Accumulation (NBIA) Phase 2
Completed NCT01376622 - Changes in Pituitary Iron and Volume With Deferasirox