The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose in
comparison to oral ferrous sulfate in improving iron deficiency anemia in children with
inflammatory bowel disease.
Drug: Intravenous iron sucrose
Drug: Oral ferrous sulfate
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Locations near you
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Full eligibility criteria for NCT01438372
Ages eligible for Study
12 Years to 17 Years
Genders eligible for Study
Accepts Healthy Volunteers
IDA (defined as a hemoglobin (Hb) concentration of ≤10.5 g/dL females) or Hb ≤11.0 g/dL (males) and Mean Corpuscular volume (MCV) < 77  plus transferrin saturation
(TSAT) < 20% and/or serum ferritin concentration less than 25 µg/L)
12- 17 years old males or females.
A signed parental permission and assent. Assent is not required in those below 13 years of age.
We will be including those who have received iron therapy in the past even if they have developed adverse reactions, as long as they have not been anaphylactic. Participants should have been "iron free" (no iron therapy - oral or IV) for two weeks prior to start of study.
Anemia other than IDA e.g hemolytic anemia, anemia due to Vitamin B12/Folic acid deficiency.
Blood transfusion or iron supplementation 2 two weeks or less before starting the study.
Renal disease - on medications such as diuretics or blood pressure lowering medications. On renal replacement therapy.
Severe reactive airway disease - classified as severe/high-risk asthma
Significant cardiac disease - on cardiac medications, including symptomatic congenital cardiac anomalies or with arrhythmias.
Anaphylaxis/hypersensitivity reaction to ferrous sulfate and/or iron sucrose
Pregnant and nursing women. A serum pregnancy test will be performed at the start of the study and on days 1, 14, and 28. Patients aged 12 years of age and are found to be pregnant are considered victims of child abuse and will be reported to child protective services and the appropriate authorities.
Any other severe concurrent illness.
All locations for NCT01438372
United States (1)
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
View full eligibility
Tris trial is registered with FDA with number: NCT01438372. The sponsor of the trial is Wayne State University and it is looking for 0 volunteers for the current phase.
Official trial title: Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease
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