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Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

NCT03777514 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-09-11

No results posted yet for this study

Summary

The aim of the study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of iron deficiency anemia (IDA) in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.

Conditions

  • IDA in the Post-bariatric Surgical Patient

Interventions

DRUG

Ferumoxytol

treatment of iron deficiency anemia with IV iron.

DRUG

Ferrous sulfate

treatment of iron deficiency anemia with oral iron

OTHER

Oral vitamin C

Oral vitamin C to be used as a placebo for participants receiving IV iron

OTHER

Intravenous normal saline

Intravenous normal saline will be used as placebo for participants receiving oral iron

Sponsors & Collaborators

Principal Investigators

  • Kimberley E Steele, MD, Ph.D · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2021-10-31
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777514 on ClinicalTrials.gov