Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01093989
First received: March 24, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The research questions to be answered by this study are:

  1. Is treatment with iron more effective at improving anemia if given at the time of a malaria episode or 1 month after the episode?
  2. Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
  3. Does timing of iron treatment affect later thinking processes and behavior?

Condition Intervention
Anemia
Inflammation
Malaria Morbidity
Cognitive Development
Dietary Supplement: Ferrous Sulphate Syrup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Immediate iron
Iron-deficient children will be randomized to receive iron concurrently with anti-malarial treatment or one month later (delayed iron group).
Dietary Supplement: Ferrous Sulphate Syrup
Iron therapy will consist of a three-month course of ferrous sulphate syrup. For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
Active Comparator: Delayed iron Dietary Supplement: Ferrous Sulphate Syrup
Iron therapy will consist of a three-month course of ferrous sulphate syrup. For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.

Detailed Description:

The study population in this study will be children who are enrolled in our ongoing study of cerebral malaria and severe malarial anemia, "Pathogenesis of cognitive/neurologic deficits in central nervous system malaria", underway in Kampala, Uganda. The pathogenesis study seeks to address the question of why children with severe malaria have later problems in thinking. The study we are now proposing will build on this study by assessing whether children with severe malaria have iron deficiency, and if they do, whether treatment with iron at the time of malaria is less effective than treatment one month later. We believe that treatment one month later may be more effective because there is data that shows that the inflammation that occurs with a malaria episode may decrease the body's ability to absorb iron in the gut and to send iron to the places it is needed, like the bone marrow and the brain. We are doing this study to see if our hypothesis about more effective iron treatment if it is delayed is correct and assessing anemia prevalence, iron status, and long-term neurobehavioral development as outcomes.

We have three study groups: children with cerebral malaria, children with severe malarial anemia, and healthy community control children. Children found to be iron deficient will be randomized to receive iron (as ferrous sulphate syrup) either immediately or at their one-month follow-up visit. At 1-, 6, and 12-month follow-up visits changes in iron and inflammation indicators will be assessed. At the 6- and 12-month visits, neurocognitive behavior will also be evaluated and compared between the immediate vs. delayed iron groups. Malaria morbidity will be assessed via home visits during the period of iron supplementation and via clinic monitoring for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children must

    1. Be between the ages of 18 mo and 5 y
    2. Reside within 20 km of study hospital
  • Children with cerebral malaria must have

    1. Coma (BCS < 3)
    2. P. falciparum on blood smear
    3. No clinical evidence or other causes of encephalopathy
  • Children with severe malarial anemia must have

    1. Hemoglobin < 5 g/dL
    2. Clinical symptoms of malaria
    3. P. falciparum on blood smear
  • Community control children must

    1. Live in same neighborhood or extended household as a child with severe malaria
    2. Be within one year of age as a child with severe malaria

Exclusion Criteria:

  • Cerebral malaria

    1. WBC > 10
    2. Positive gram stain or culture

Severe malarial anemia

  1. Impaired conscious on physical exam
  2. Seizure activity prior to or during physical exam
  3. Any other evidence of CNS disease
  4. All exclusion criteria of CM except no lumbar puncture required

Community control children

  1. All exclusion criteria for CM
  2. Any active illness, recent illness, or recovery from illness
  3. Chronic illness requiring medical care
  4. Medical abnormalities on screening history of physical exam
  5. CC control with a positive malaria smear will be treated but will not be excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093989

Contacts
Contact: Sarah E Cusick, Ph.D. 612 625-8549 scusick@umn.edu

Locations
Uganda
Mulago Hospital Recruiting
Kampala, Uganda
Contact: Robert Opoka, MD       opokabob@yahoo.com   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Chandy C John, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01093989     History of Changes
Other Study ID Numbers: 0909M72852, 1U01HD064698-01
Study First Received: March 24, 2010
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Inflammation
Malaria
Hematologic Diseases
Pathologic Processes
Protozoan Infections
Parasitic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014