Impact of Host Iron Status and Iron Supplement Use on Erythrocytic Stage of Plasmodium Falciparum

NCT01027663 | Completed

• 1 other identifier: 09-0559
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform laboratory based studies to determine if the growth and development of the malaria parasite is effected by iron status of its host (the person infected with the malaria parasite). Iron deficiency affects over 500 million people including many pregnant women and children from areas of the world that are plagued by malaria. Some population based studies have suggested that iron deficiency protects people from getting malaria and this has raised questions about the wisdom of public health policies that provide universal iron supplementation in countries where malaria is common. We will use red blood cells and sera from patients with iron deficiency anemia, hereditary hemochromatosis and normal individuals who are taking iron supplements to look at this question in a very systematic way. This study should provide information for or against a possible mechanism by which iron deficiency may affect the malaria parasite. The results will contribute to efforts to develop evidence-based public health policies on iron supplementation policies in malaria-endemic areas. There are three different types of individuals involved in this study (1) people with iron deficiency anemia who will be taking iron supplementation (2) people without iron deficiency anemia who will be taking iron supplementation and (3) people with a condition called hereditary hemochromatosis who have an excess of iron in their bodies.

Conditions

Iron Deficiency Anemia; Malaria

Keywords

anemia; malaria

Study Arms (3)

Iron Deficiency Anemia

NO INTERVENTION

Hereditary Hemochromatosis

NO INTERVENTION

Iron Supplements

ACTIVE COMPARATOR

Dietary Supplement: Iron Supplement

Interventions

Iron Supplement DIETARY_SUPPLEMENT

Iron supplementation (325 mg of ferrous sulfate) once daily for the 2 month duration of the study.

Also known as: Ferrous sulfate

Iron Supplements

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All study participants will need to meet the following eligibility criteria for participation in the study:
• years of age or older
• Agree to HIV testing
• No known malignancy
• Agree to pregnancy testing (when applicable)
• Do not have sickle cell disease or trait
• Do not have thalassemia or thalassemia trait
• Not taking iron supplementation
• Have O+ or A+ blood group, and
• Consent to participate in the study
• In addition to the above common study screening tests, additional specific eligibility criteria for the three study groups are as follows:
• Individuals with iron deficiency:
• Iron deficiency will be diagnosed using the biochemical parameters listed below
• Serum iron: \<40 µg/dL
• Iron binding capacity (transferrin): \<40 µg/dL

You may not qualify if:

• Patients with HIV, that are pregnant, and those with Sickle cell anemia/trait or Thalassemia/Thal trait will not be eligible to participate in this study as these conditions could interfere with the outcomes of the in vitro studies performed in this proposal.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Malaria; Anemia

Interventions

Iron-Dextran Complex; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Raj Kasthuri, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 9, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 8, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)