Evaluation of Fe Absorption From Iron Salt in Milk | NCT05642689 | Trialant

Evaluation of Fe Absorption From Iron Salt in Milk | NCT05642689 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Comparison of iron absorption from FAP to Ferrous sulfate in milk	Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe
2	Other	Comparison of iron absorption from ferric pyrophosphate to Ferrous sulfate in milk	Other: Iron fortified milk with iron salt labelled with 58Fe and 57Fe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron fortified milk with iron salt labelled with 58Fe and 57Fe	Other	Oral administration of a serving of iron labelled with stable isotope (2 mg Fe per serving) in 200ml of reconstituted milk once after a overnight fast. The alternate test drink was fed on the following day in the same fashion. The administration was repeated on day 3 and 4.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate	It is based on calculated amount of 58Fe and 57Fe appearing in the blood. For that the shift of the iron isotope ratios in the blood samples collected 14 days after the last consumption of the last test drink are measured. The calculation of circulating iron is based on blood volume and hemoglobin concentration. For calculations of fractional absorption, 90% incorporation of the absorbed iron into red blood cells is assumed. The relative iron absorption from FAP and from ferric pyrophosphate relative to ferrous sulfate is then calculated as follows: Relative bioavailability of a salt (RBV %) = ( Fe absorption from an iron salt/ Fe absorption from ferrous sulfate)∗ 100. The comparison of the iron absorption from ferric pyrophosphate to that from ferric ammonium phosphate will be made by statistical analysis of data measured and calculated as described above.	14 days post isotope consumption

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22956195	Background	Walczyk T, Kastenmayer P, Storcksdieck Genannt Bonsmann S, Zeder C, Grathwohl D, Hurrell RF. Ferrous ammonium phosphate (FeNH(4)PO(4)) as a new food fortificant: iron bioavailability compared to ferrous sulfate and ferric pyrophosphate from an instant milk drink. Eur J Nutr. 2013 Jun;52(4):1361-8. doi: 10.1007/s00394-012-0445-y. Epub 2012 Sep 6.