NCT01754701

Brief Summary

The purpose of this study is to determine whether iron therapy given to iron-deficient Ugandan children with moderate-to-severe anemia and clinical malaria is better absorbed and incorporated into red blood cells if it is given concurrently with antimalarial treatment on Day 0 (immediate group) or 4 weeks after antimalarial treatment on Day 28 (delayed group). Use of iron stable isotopes 57Fe and 58Fe will permit measurement of red blood cell iron incorporation on Day 0 and Day 28 in all children. The investigators hypothesize that red cell iron incorporation at the time of initial supplement administration will be greater in children receiving delayed vs. immediate iron (Aim 1), and children in the delayed group will also have greater hematological recovery on Day 56 than children in the immediate group (Aim 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

December 18, 2012

Last Update Submit

November 25, 2015

Conditions

Iron DeficiencyMalariaNutritionGlobal Health

Outcome Measures

Primary Outcomes (1)

  • Percent red blood cell iron incorporation on Day 0 in children in the immediate group vs. percent red blood cell iron incorporation on Day 28 in children in the delayed group

    All children will receive iron stable isotope 57Fe on Day 0 and iron stable isotope 58Fe on Day 28. Children in the immediate group will begin 27 days of daily iron syrup at home on Day 1. Children in the delayed group will begin 27 days of daily iron syrup at home on Day 29. All children will be assessed at the hospital at Day 28 and Day 56.

    56 days

Secondary Outcomes (1)

  • Hematological recovery in the immediate vs. delayed groups on Day 56

    56 days

Study Arms (2)

Immediate iron

EXPERIMENTAL

Children who start 4 weeks of iron therapy on Day 0

Dietary Supplement: Immediate iron

Delayed iron

EXPERIMENTAL

Children who start 4 weeks of iron therapy on Day 28

Dietary Supplement: Delayed iron

Interventions

Immediate ironDIETARY_SUPPLEMENT

Children who start 4 weeks of iron therapy on Day 0

Also known as: Ferrous sulfate syrup
Immediate iron
Delayed ironDIETARY_SUPPLEMENT

Children who start 4 weeks of iron therapy on Day 28

Delayed iron

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months of age
  • Hemoglobin 5.0 - 9.9 g/dL according to HemoCue
  • Temperature \> 37.5°C or history of fever in past 24 hours
  • P. falciparum on blood smear at Acute Care Unit
  • Residence\<50 km of study hospital

You may not qualify if:

  • Impaired consciousness on physical exam or history of coma with present illness
  • Seizure activity prior to or during admission
  • Known sickle cell disease 4) Acute malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

  • Cusick SE, Opoka RO, Abrams SA, John CC, Georgieff MK, Mupere E. Delaying Iron Therapy until 28 Days after Antimalarial Treatment Is Associated with Greater Iron Incorporation and Equivalent Hematologic Recovery after 56 Days in Children: A Randomized Controlled Trial. J Nutr. 2016 Sep;146(9):1769-74. doi: 10.3945/jn.116.233239. Epub 2016 Jun 29.

    PMID: 27358418DERIVED

MeSH Terms

Conditions

Iron DeficienciesMalaria

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Sarah Cusick, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 21, 2012

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

UG(1)