NCT05233709: OTf

The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women

Completed NA Last updated 10 June 2022

What this trial tests

NA trial testing FeSO4 + OTf in Iron-deficiency in 35 participants. Completed in 20 May 2022.

Timeline

25 April 2022

Primary endpoint
20 May 2022

20 May 2022

Quick facts

Lead sponsor	Swiss Federal Institute of Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	35
Start date	25 April 2022
Primary completion	20 May 2022
Estimated completion	20 May 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• FeSO4 + OTf
• FeSO4 + Lf
• FeSO4

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

Swiss Federal Institute of Technology

Who can join

Adults 18 to 45, female only, with Iron-deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants \[19\]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women.

OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.