NCT03453918: POLYFER

Effects of Polyphenols on Iron Absorption in Iron Overload Disorders.

Completed NA Last updated 1 April 2019

What this trial tests

NA trial testing polyphenols in Dysmetabolic Iron Overload Syndrome in 41 participants. Completed in 20 July 2018.

Timeline

9 April 2018

Primary endpoint
20 July 2018

20 July 2018

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	41
Start date	9 April 2018
Primary completion	20 July 2018
Estimated completion	20 July 2018
Sites	1 location across France

Drugs / interventions tested

• polyphenols
• Placebo

Conditions studied

• Dysmetabolic Iron Overload Syndrome — all drugs for Dysmetabolic Iron Overload Syndrome →
• Genetic Hemochromatosis — all drugs for Genetic Hemochromatosis →
• Iron Absorption — all drugs for Iron Absorption →
• Polyphenols — all drugs for Polyphenols →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Dysmetabolic Iron Overload Syndrome or Genetic Hemochromatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dysmetabolic iron overload syndrome and genetic hemochromatosis are frequent causes of iron overload. Polyphenols are efficient iron-chelators. Investigator hypothesize that polyphenol supplementation can reduce iron absorption in iron overload disease. Iron absorption can be studied by the area-under-the-curve of serum iron after iron oral loading. The primary outcome is the decrease of post-prandial serum iron after rich-iron meal, due to polyphenol supplementation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of procyanidin on dietary iron absorption in hereditary hemochromatosis and in dysmetabolic iron overload syndrome: A crossover double-blind randomized controlled trial.
   Lobbes H, Gladine C, Mazur A, Pereira B, et al · · 2020 · cited 7× · PMID 30792142 · DOI 10.1016/j.clnu.2019.02.012