Ethical approval
hypophosphatemia
HYPOPHOSPHATEMIA, MAY, IRON DEFICIENCY, IRON DEFICIENCY ANAEMIA, SECONDARY
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).