NCT03196882 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aranda N, Ribot B, Garcia E, Viteri FE, Arija V
Pre-pregnancy iron reserves, iron supplementation during pregnancy, and birth weight. Early Hum Dev. 2011 Dec;87(12):791-7. doi: 10.1016/j.earlhumdev.2011.06.003. Epub 2011 Jun 30.
Hernández-Martínez C, Canals J, Aranda N, Ribot B, Escribano J, Arija V
Effects of iron deficiency on neonatal behavior at different stages of pregnancy. Early Hum Dev. 2011 Mar;87(3):165-9. doi: 10.1016/j.earlhumdev.2010.12.006. Epub 2011 Jan 22.
Peña-Rosas JP, Viteri FE
Effects and safety of preventive oral iron or iron+folic acid supplementation for women during pregnancy. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004736. doi: 10.1002/14651858.CD004736.pub3. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD004736.
Recommendations to prevent and control iron deficiency in the United States
Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998 Apr 3;47(RR-3):1-29.
Ribot B, Aranda N, Viteri F, Hernández-Martínez C, Canals J, Arija V
Depleted iron stores without anaemia early in pregnancy carries increased risk of lower birthweight even when supplemented daily with moderate iron. Hum Reprod. 2012 May;27(5):1260-6. doi: 10.1093/humrep/des026. Epub 2012 Feb 21.

Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. Randomized Clinical Trial (ECLIPSES)

Clinical trial NCT03196882 - References