NCT05225545 - 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)

Carrier J, Aghdassi E, Cullen J, Allard JP
Iron supplementation increases disease activity and vitamin E ameliorates the effect in rats with dextran sulfate sodium-induced colitis. J Nutr. 2002 Oct;132(10):3146-50. doi: 10.1093/jn/131.10.3146.
Gasche C, Lomer MC, Cavill I, Weiss G
Iron, anaemia, and inflammatory bowel diseases. Gut. 2004 Aug;53(8):1190-7. doi: 10.1136/gut.2003.035758.
Lugg S, Beal F, Nightingale P, Bhala N, Iqbal T
Iron treatment and inflammatory bowel disease: what happens in real practice? J Crohns Colitis. 2014 Aug;8(8):876-80. doi: 10.1016/j.crohns.2014.01.011. Epub 2014 Jan 31.
Seril DN, Liao J, Yang GY, Yang CS
Oxidative stress and ulcerative colitis-associated carcinogenesis: studies in humans and animal models. Carcinogenesis. 2003 Mar;24(3):353-62. doi: 10.1093/carcin/24.3.353.

Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

Clinical trial NCT05225545 - References