Hansen, Rebecka
Sommer, Veronika Markova
Pinborg, Anja
Krebs, Lone
Thomsen, Lars Lykke
Moos, Torben
Holm, Charlotte http://orcid.org/0000-0003-2278-2384
Funding for this research was provided by:
Pharmacosmos A/S
Article History
Received: 24 June 2022
Accepted: 22 August 2022
First Online: 15 September 2022
Declarations
:
: The trial was sponsored and fully funded by Pharmacosmos A/S, Holbæk, Denmark. The sponsor was involved in the study design, analysis and interpretation of the data, and approval of the final manuscript. Charlotte Holm was the primary investigator of the trial. Lars Lykke Thomsen is employed by Pharmacosmos A/S, as was Veronika Markova Sommer during the trial. Rebecka Hansen was employed by the institution with salary costs funded by Pharmacosmos A/S. Charlotte Holm and Rebecka Hansen have served on advisory boards for Pharmacosmos A/S. Charlotte Holm has received speaker honoraria from Pharmacosmos A/S. The remaining authors have no conflicts of interest to declare.
: The trial was approved by the Danish Medicines Agency and the Danish Scientific Ethics Committees (H-17005699) and registered in the European Clinical Trials Database (EudraCT no.: 2017–000776-29) and on ClinicalTrials.gov (NCT03188445). The authorities approved the study protocol in May 2017 and further amendments in November 2017 (key changes: inclusion criteria of iron deficiency anaemia changed to both non-anaemic and anaemic iron deficiency, and the upper gestational time window changed from 16 + 0 to 19 + 0 weeks). The first randomisation was performed in December 2017; hence, these first amendments were approved before the randomisation of any participants. Additional amendments were approved in July 2018 (key change: upper gestational age time window changed from 19 + 0 to 21 + 0 weeks) and September 2019 (key changes: adding hypophosphatemia as a secondary endpoint and including a detailed definition of obstetric and perinatal endpoints).
: Written informed consent was obtained from all individual participants included in the study.