IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2011

Primary Completion Date

February 29, 2012

Study Completion Date

March 31, 2012

Conditions
Iron Deficiency AnemiaInflammatory Bowel Disease
Interventions
DRUG

Intravenous iron sucrose

Intravenous iron sucrose will be administered on days 1, 7, 14, and 21 using the formula: Total dose: (normal Hb for age - initial Hb)/100 x blood volume (ml) x 3.4 x 1.5. First dose will be infused over 30 minutes, with subsequent doses administered over 15 minutes if no reactions encountered.

DRUG

Oral ferrous sulfate

Oral ferrous sulfate will be administered at 3 mg/kg/day divided into 2 doses for 28 days. A tablet form of ferrous sulfate (325 mg with 65 mg of elemental iron per tablet) will be used.

Trial Locations (1)

48201

Children's Hospital of Michigan, Detroit

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Children's Hospital of Michigan

OTHER

collaborator

American Regent, Inc.

INDUSTRY

lead

Wayne State University

OTHER

NCT01438372 - IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD | Biotech Hunter | Biotech Hunter