drugset / Trial / NCT05225545
Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
Phase 3
Unknown
30 enrolled
American University of Beirut Medical Center
Pharma M SAL, Lebanon · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.
Timeline
- Start
- 2019-11-04
- Primary completion
- 2024-05-04
- Completion
- 2024-05-04
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 195 mg | Oral |
| Subject | Sucrosomial Iron | Unknown | 30 mg | — |