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IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania

NCT02541708 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2017-04-25

No results posted yet for this study

Summary

Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country

Conditions

  • Iron-Deficiency Anemia

Interventions

DRUG

Ferric carboxymaltose

Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia

DRUG

Ferrous sulfate + folic acid

Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Ifakara Health Institute

    lead OTHER

Principal Investigators

  • Sandrine Meyer-Monard, PD DrMed · Swiss Tropical & Public Health Institute

  • Salim Abdulla, MD,PhD · Ifakara Health Institute

  • Marcel Tanner, PhD, MPH · Swiss Tropical & Public Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Tanzania

Study Locations

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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 NCT02541708 on ClinicalTrials.gov