Malaria and the Safety of Iron Supplements and Iron Fortification

Summary

The primary study hypothesis of the investigators is that administration of an iron supplement between meals at a dose like that used in the Pemba trial (\~1 mg Fe/kg) during P. falciparum parasitemia will increase plasma non-transferrin-bound iron. A key subsidiary hypothesis is that iron administered with meals in amounts used in food fortification (\~0.1 mg Fe/kg) will not produce plasma non-transferrin-bound iron.

This research will be carried out at the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand. The studies are intended to help understand how giving iron and folic acid to preschool children in Pemba, Zanzibar, Tanzania, (the "Pemba trial") in the doses recommended by the World Health Organization, could have resulted in an increase in hospitalizations and deaths. The investigators will examine the most likely explanation, that the dose of iron supplements used in the Pemba trial produced iron in the blood not bound to the usual carrier for iron (a protein called "transferrin"), that is called "non-transferrin-bound iron", abbreviated as NTBI. In children with malaria, this NTBI might favor the growth of malarial parasites or other causes of infection. At present, no studies have been carried out to see if NTBI is present after giving iron to patients with malaria. Using non-radioactive forms of iron (called "stable isotopes"), the investigators will study iron absorption and NTBI after giving a single dose of iron (like that used in the Pemba trial) one day after treatment for malaria has been started, while patients still have malaria parasites in the blood, and then again two weeks later, after the malaria has been cured. The investigators will study adults admitted to the Hospital for Tropical Diseases in Bangkok, Thailand, with malaria. For reasons of safety, the investigators have chosen to study adults in the hospital rather than children living in an area like Pemba but the results should also apply to children. The outcome of this research will help us design ways of safely giving iron in malarious areas to adults and children to prevent or treat iron deficiency.

Conditions

• Iron Deficiency

Interventions

DIETARY_SUPPLEMENT

Ferrous sulfate

Ferrous sulfate, \~1 mg Fe/kg body weight, given as a single dose in the fasting state.

DIETARY_SUPPLEMENT

Ferrous sulfate

Ferrous sulfate, \~1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal.

DIETARY_SUPPLEMENT

Ferrous sulfate

Ferrous sulfate, \~1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal with added oil.

DIETARY_SUPPLEMENT

Ferrous sulfate

Ferrous sulfate, \~0.1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Gary M. Brittenham, M.D. · Columbia University

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• Thailand

Study Locations