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

NCT01093989 | Completed DMC

• 2 other identifiers: 0909M728521U01HD064698-01
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

The research questions to be answered by this study are:

1. 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. 2.Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
3. 3.Does timing of iron treatment affect later thinking processes and behavior?

Conditions

Anemia; Inflammation; Malaria Morbidity; Cognitive Development

Outcome Measures

Primary Outcomes (1)

• Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups

  6 months

Study Arms (2)

Immediate iron

PLACEBO COMPARATOR

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

Delayed iron

ACTIVE COMPARATOR

Dietary Supplement: Ferrous Sulphate Syrup

Interventions

Ferrous Sulphate Syrup DIETARY_SUPPLEMENT

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.

Delayed iron; Immediate iron

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All children must
• Be between the ages of 18 mo and 5 y
• Reside within 20 km of study hospital
• Children with cerebral malaria must have
• Coma (BCS \< 3)
• P. falciparum on blood smear
• No clinical evidence or other causes of encephalopathy
• Children with severe malarial anemia must have
• Hemoglobin \< 5 g/dL
• Clinical symptoms of malaria
• P. falciparum on blood smear
• Community control children must
• Live in same neighborhood or extended household as a child with severe malaria
• Be within one year of age as a child with severe malaria

You may not qualify if:

• Cerebral malaria
• WBC \> 10
• Positive gram stain or culture
• Severe malarial anemia
• Impaired conscious on physical exam
• Seizure activity prior to or during physical exam
• Any other evidence of CNS disease
• Community control children
• Any active illness, recent illness, or recovery from illness
• Chronic illness requiring medical care
• Medical abnormalities on screening history of physical exam
• CC control with a positive malaria smear will be treated but will not be excluded from the study.

Sponsors & Collaborators

• University of Minnesota: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (3)

• Blatt DB, Hanisch B, Co K, Datta D, Bond C, Opoka RO, Cusick SE, Michelow IC, John CC. Impact of Oxidative Stress on Risk of Death and Readmission in African Children With Severe Malaria: A Prospective Observational Study. J Infect Dis. 2022 Sep 4;226(4):714-722. doi: 10.1093/infdis/jiac234.

  PMID: 35678643 DERIVED

• Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Delayed iron improves iron status without altering malaria risk in severe malarial anemia. Am J Clin Nutr. 2020 May 1;111(5):1059-1067. doi: 10.1093/ajcn/nqaa004.

  PMID: 32005992 DERIVED

• Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Comparison of iron status 28 d after provision of antimalarial treatment with iron therapy compared with antimalarial treatment alone in Ugandan children with severe malaria. Am J Clin Nutr. 2016 Mar;103(3):919-25. doi: 10.3945/ajcn.115.117820. Epub 2016 Feb 3.

  PMID: 26843153 DERIVED

MeSH Terms

Conditions

Anemia; Inflammation

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chandy C John, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

UG (1)