AnemiaNCT01093989
Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
A study testing Ferrous Sulphate Syrup in people with Anemia and Inflammation, run by University of Minnesota at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Inflammation, Malaria Morbidity
- What is being tested?
- Ferrous Sulphate Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- Any other evidence of CNS disease
- All exclusion criteria of CM except no lumbar puncture required
- Community control children
- All exclusion criteria for CM
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The research questions to be answered by this study are:
- Is treatment with iron more effective at improving anemia if given at the time of a malaria episode or 1 month after the episode?
- Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
- Does timing of iron treatment affect later thinking processes and behavior?
Read the 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.
- Conditions
- Anemia, Inflammation, Malaria Morbidity, Cognitive Development
- Being tested
- Ferrous Sulphate Syrup
- Medical subject headings
- Anemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulphate SyrupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Ferrous Sulphate Syrup |
| Delayed iron | Active comparator | Not described Receives: Dietary Supplement: Ferrous Sulphate Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Chandy C John, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093989
- Sponsor's protocol ID
- 0909M72852
- Other IDs
- 1U01HD064698-01
- Status last verified
- May 2015
- First submitted
- 24 Mar 2010
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35678643Cusick 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.
PubMed 32005992Cusick 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.
PubMed 26843153
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
- ClinicalTrials.gov ID
- NCT01093989
- Acronym / sponsor ID
- 0909M72852
- Conditions
- Anemia, Inflammation, Malaria Morbidity, Cognitive Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research questions to be answered by this study are:
- Is treatment with iron more effective at improving anemia if given at the time of a malaria episode or 1 month after the episode?
- Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
- Does timing of iron treatment affect later thinking processes and behavior?
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate iron | Placebo comparator | Dietary Supplement: Ferrous Sulphate SyrupIron-deficient children will be randomized to receive iron concurrently with anti-malarial treatment or one month later (delayed iron group). |
| Delayed iron | Active comparator | Dietary Supplement: Ferrous Sulphate Syrup |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- All children must
- Children with cerebral malaria must have
- Children with severe malarial anemia must have
- Community control children must
Key exclusion criteria (14 listed)
- Cerebral malaria
- Severe malarial anemia
- Impaired conscious on physical exam
- Seizure activity prior to or during physical exam
- Any other evidence of CNS disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous Sulphate SyrupIron 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. | Dietary supplement | Delayed iron, Immediate iron |
Primary outcome
Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 35678643Blatt 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.
- Derived from this study: PubMed 32005992Cusick 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.
- Derived from this study: PubMed 26843153Cusick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandy C John, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulphate Syrup in people with Anemia and Inflammation, run by University of Minnesota at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093989, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.