Iron Deficiency AnemiaOptiMNCT03897673
Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
A study testing Early Iron and Delayed Iron in people with Iron Deficiency Anemia and Iron-deficiency, run by University of Minnesota at 1 site in Uganda.
Trial summary
Daily iron (ferrous sulfate, 2 mg/kg/day) or placebo syrup for first four months (112 days) of the 12-month (336-day) study. Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Read more about this study
- Who is it for?
- Ages 6 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Iron-deficiency, Anemia, Iron Deficiency
- What is being tested?
- Early Iron and Delayed Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2019to 15 Jan 2025
- 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 6 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hemoglobin 7.0 - 9.9 g/dL
- ZPP > = 80 µmol/mol heme
- P. falciparum positive by Giemsa smear or RDT positive
- Temperature ≥ 37.5C or history of fever in past 24 hours
- Same neighborhood, extended household or nearby neighborhood of a child with malaria
- Same age group as a child with malaria
- Hemoglobin > = 10.0 g/dL
Who cannot join
- Any WHO criterion for severe malaria, including severe anemia, prostration, cerebral malaria, repeated seizures or symptoms like persistent vomiting, high temperature (>39.5°C), or tea-colored urine
- Severe malnutrition, as evidenced by severe wasting or bilateral pitting edema
- Known sickle cell disease
- Acute hemorrhage
- Known cancer or leukemia
- Caregiver does not understand English or Luganda
Show all 13Show fewer
- Clinical malaria infection or any active illness within the past 4 weeks requiring medical care
- Chronic illness requiring medical care
- Major medical abnormalities on screening history or physical exam, including measured temperature ≥ 37.5°C
- Known developmental delay or neurologic disorder
- Prior history of coma
- Caregiver does not understand English or Luganda
- Other severe illness such as pneumonia or cardiac failure
Trial locations and contacts
1 site in 1 country.
About this study
Daily iron (ferrous sulfate, 2 mg/kg/day) or placebo syrup for first four months (112 days) of the 12-month (336-day) study. Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Children in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months.
Read the detailed description
Provision of sufficient iron for brain development in children living in malaria-endemic areas while also protecting them from infection is an unachieved public health goal for >10 years. The 2006 landmark study on malaria-endemic Pemba Island brought the complicated relationship between iron and malaria to the world stage by reporting universal prophylactic iron supplementation increases the risk of child hospitalization and death. Treating iron deficiency in children who have malaria is also an unsolved challenge. In sub-Saharan Africa, iron deficiency and malaria coexist, frequently causing a multifactorial anemia that is a primary cause of hospitalization and mortality in children <5 y. The current World Health Organization standard-of-care regimen of concurrent treatment with antimalarial medication and iron therapy has been unsuccessful, with frequent reports of subsequent infection, including malaria, persistent iron deficiency, and unresolved anemia.
One solution to effectively treat coexisting malaria and iron deficiency is to stagger interventions, treating malaria first and delaying iron. The inflammatory response against malaria induces high levels of the protein hepcidin, which reduces intestinal iron absorption and prohibits release of iron from reticulo-endothelial cells. Iron given orally during or shortly after a malaria episode is thus not well absorbed or distributed to red blood cells or the brain. Moreover, unabsorbed iron in the gut may promote the growth of pathogenic bacteria, potentially leading to subsequent infectious morbidity. A pilot study was recently completed in Ugandan children with malaria and iron deficiency that used iron stable isotopes to test whether iron given 28 days after (delayed group) or concurrently with (immediate group) antimalarial treatment was better incorporated into red blood cells (1R03HD074262). It was found that delayed iron was incorporated twice as well as immediate iron and that iron status at 56 days was similar between groups. An important finding was that children in the immediate group had a higher incidence of infections in the 56-day follow-up period. In this application, the team proposes a large-scale, randomized clinical trial with 12 months follow up powered to capture long-term differences in iron status, morbidity, and neurobehavioral development as a function of immediate or delayed iron following treatment for malaria and iron deficiency. The gut microbiome will be analyzed to elucidate a mechanism of any differences in incidence of infections.
One long-term goal is to develop safe and effective strategies for managing concurrent malaria and iron deficiency in children, with reduction of infections and optimization of neurobehavioral development representing successful outcomes. The objective of this application is to conduct a placebo-controlled, randomized clinical trial to determine whether iron therapy begun with vs. 28 days after antimalarial treatment in Ugandan children 6-48 months with malaria and iron deficiency leads to better iron status, fewer infections, and better neurobehavioral development after 12 months. The central hypothesis is that better iron incorporation and lower incidence of infectious illness observed with delayed iron in our short-term, physiology-focused R03 study will translate into better long-term iron status, fewer episodes of infection, and better neurobehavioral outcomes after 12 months. The rationale is that this study will determine if staggering antimalarial treatment and iron therapy protects against immediate morbidity while also optimizing long-term neurobehavioral development. The Specific Aims are:
Aim 1: Establish the effect of immediate vs. delayed iron treatment on long-term iron status.
It is hypothesized that delayed iron will result in better iron status 6 and 12 months after treatment for malaria due to better initial iron absorption and utilization as compared to the immediate iron group.
Aim 2: Determine the effect of delayed iron treatment on the incidence of infectious illness.
It is hypothesized that the better absorbed delayed iron will result in fewer infections in the 6 and 12 months after treatment for malaria due, in part, to a less pathogenic intestinal microbiome profile.
Aim 3: Establish the effect of delayed iron treatment on neurobehavioral development.
It is hypothesized that delayed iron will result in better neurobehavioral outcomes (as assessed by standardized cognitive and behavioral tests) due to better iron absorption and utilization.
Anticipated Impact: Untreated iron deficiency may protect a child from malaria and other infections, but the consequent potentially permanent damage to the developing brain is an unacceptable alternative. Establishment of methods to effectively ensure brain iron health while protecting the child from infection will promote attainment of full cognitive and behavioral development for tens of millions of children worldwide suffering from malaria and iron deficiency.
- Conditions
- Iron Deficiency Anemia, Iron-deficiency, Anemia, Iron Deficiency, Anemia, Anemia in Children, Malaria
- Being tested
- Early Iron, Delayed Iron
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early IronDietary supplement
iron syrup for the first three months (84 days) and placebo syrup for the fourth month
Delayed IronDietary supplement
placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months
| Study group | Role | What they receive |
|---|---|---|
| Early Iron | Experimental | Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Receives: Dietary Supplement: Early Iron |
| Delayed Iron | Experimental | Children in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months. Receives: Dietary Supplement: Delayed Iron |
| Community Control Children | No intervention | Healthy, non-anemic community children will be enrolled from the same households and villages as the children with malaria. They will not have ZPP tested or receive iron, but they will also be under the same illness surveillance as the children with malaria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of iron deficiency
Number of participants who are iron deficient (defined as a zinc protoporphyrin (ZPP) concentration greater than or equal to 80 umol/mol heme) at 6-months follow-up in the early iron vs. delayed iron treatment groups
Measured: 6-months
All-cause incidence of infectious illness
Number of participants who report an infection and total number of infections reported to a study medical officer in the early iron vs. delayed iron treatment groups. This includes all infectious illness including clinical malaria episodes.
Measured: 6-months
Effect on neurobehavioral development: BRS
Behavior Rating Scales (BRS) scores at 12 months follow up in the early iron vs. delayed iron treatment groups. BRS assesses socioemotional behavior. Scores range from 1-5. Higher raw scores for Fearful/Wary Affect, Negative Affect, and Hyperactivity/Over-activity indicate less optimal behavior, as do lower raw scores for Positive Affect, Adaptation to Change, Exploration and Activity Level.
Measured: 12-months
Effect on neurobehavioral development: MSEL
Mullen Scales of Early Learning (MSEL) scores at 12 months follow up in the early iron vs. delayed iron treatment groups.The MSEL assesses motor, visual, and language ability and is used to measure cognitive ability. Scores from fine motor, visual reception, receptive language, and expressive language scales are summed to give the early learning composite score, a measure of overall cognitive ability. Each sub-scale is standardized to calculate a standard score, percentile, and age-equivalent score. Composite scores range from 0 to 100 with 100 indicating greater cognitive ability.
Measured: 12-months
Secondary outcomes (10)
ZPP
Prevalence of zinc protoporphyrin (ZPP) ≥ 80 umol/mol heme in the early iron vs. delayed iron treatment groups
Measured: 12-months
Iron status: Hemoglobin
Concentrations of hemoglobin in the immediate vs. delayed groups
Measured: 6- and 12-months
Iron status: ferritin
Concentrations of ferritin in the early iron vs. delayed iron treatment groups
Measured: 6- and 12-months
Iron status: soluble transferrin receptor (sTFR)
Concentrations of sTFR in the early iron vs. delayed iron treatment groups
Measured: 6- and 12-months
Iron status: hepcidin
Concentrations of hepcidin in the early iron vs. delayed iron treatment groups
Measured: 6- and 12-months
Iron status: C-reactive Protein (CRP)
Concentrations of CRP in the early iron vs. delayed iron treatment groups
Measured: 6- and 12-months
All-cause infectious episodes
Incidence of all-cause infectious episodes and incidence of clinical malaria episodes during the 12-months follow-up period; incidence of all-cause and malaria-specific hospitalizations
Measured: 12-months
Proteobacteria
Change in relative fecal abundance of Proteobacteria
Measured: Baseline, 6-months, 12-months
Child Behavior Checklist (CBCL)
CBCL scores at 12 months follow up. Preschool Child Behavioral Checklist (P-CBCL) is a parent-report checklist that assesses internalizing, externalizing, and total behavioral problems. Higher scores indicate more problematic behavior or diminished function.
Measured: 12-months
Behaviors Related to Executive Function (BRIEF)
BRIEF scores at 12 months follow up. Behavior Rating Inventory of Executive Functioning, Preschool edition (BRIEF-P) is a parent-report checklist that assesses global executive function. Higher scores indicate more problematic behavior or diminished function.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Sep 2019
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897673
- Sponsor's protocol ID
- STUDY00001235
- Acronym
- OptiM
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2019
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
- ClinicalTrials.gov ID
- NCT03897673
- Acronym / sponsor ID
- OptiM / STUDY00001235
- Conditions
- Iron Deficiency Anemia, Iron-deficiency, Anemia, Iron Deficiency, Anemia, Anemia in Children, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
Daily iron (ferrous sulfate, 2 mg/kg/day) or placebo syrup for first four months (112 days) of the 12-month (336-day) study. Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Children in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months.
Detailed description
Provision of sufficient iron for brain development in children living in malaria-endemic areas while also protecting them from infection is an unachieved public health goal for >10 years. The 2006 landmark study on malaria-endemic Pemba Island brought the complicated relationship between iron and malaria to the world stage by reporting universal prophylactic iron supplementation increases the risk of child hospitalization and death. Treating iron deficiency in children who have malaria is also an unsolved challenge. In sub-Saharan Africa, iron deficiency and malaria coexist, frequently causing a multifactorial anemia that is a primary cause of hospitalization and mortality in children <5 y. The current World Health Organization standard-of-care regimen of concurrent treatment with antimalarial medication and iron therapy has been unsuccessful, with frequent reports of subsequent infection, including malaria, persistent iron deficiency, and unresolved anemia.
One solution to effectively treat coexisting malaria and iron deficiency is to stagger interventions, treating malaria first and delaying iron. The inflammatory response against malaria induces high levels of the protein hepcidin, which reduces intestinal iron absorption and prohibits release of iron from reticulo-endothelial cells. Iron given orally during or shortly after a malaria episode is thus not well absorbed or distributed to red blood cells or the brain. Moreover, unabsorbed iron in the gut may promote the growth of pathogenic bacteria, potentially leading to subsequent infectious morbidity. A pilot study was recently completed in Ugandan children with malaria and iron deficiency that used iron stable isotopes to test whether iron given 28 days after (delayed group) or concurrently with (immediate group) antimalarial treatment was better incorporated into red blood cells (1R03HD074262). It was found that delayed iron was incorporated twice as well as immediate iron and that iron status at 56 days was similar between groups. An important finding was that children in the immediate group had a higher incidence of infections in the 56-day follow-up period. In this application, the team proposes a large-scale, randomized clinical trial with 12 months follow up powered to capture long-term differences in iron status, morbidity, and neurobehavioral development as a function of immediate or delayed iron following treatment for malaria and iron deficiency. The gut microbiome will be analyzed to elucidate a mechanism of any differences in incidence of infections.
One long-term goal is to develop safe and effective strategies for managing concurrent malaria and iron deficiency in children, with reduction of infections and optimization of neurobehavioral development representing successful outcomes. The objective of this application is to conduct a placebo-controlled, randomized clinical trial to determine whether iron therapy begun with vs. 28 days after antimalarial treatment in Ugandan children 6-48 months with malaria and iron deficiency leads to better iron status, fewer infections, and better neurobehavioral development after 12 months. The central hypothesis is that better iron incorporation and lower incidence of infectious illness observed with delayed iron in our short-term, physiology-focused R03 study will translate into better long-term iron status, fewer episodes of infection, and better neurobehavioral outcomes after 12 months. The rationale is that this study will determine if staggering antimalarial treatment and iron therapy protects against immediate morbidity while also optimizing long-term neurobehavioral development. The Specific Aims are:
Aim 1: Establish the effect of immediate vs. delayed iron treatment on long-term iron status.
It is hypothesized that delayed iron will result in better iron status 6 and 12 months after treatment for malaria due to better initial iron absorption and utilization as compared to the immediate iron group.
Aim 2: Determine the effect of delayed iron treatment on the incidence of infectious illness.
It is hypothesized that the better absorbed delayed iron will result in fewer infections in the 6 and 12 months after treatment for malaria due, in part, to a less pathogenic intestinal microbiome profile.
Aim 3: Establish the effect of delayed iron treatment on neurobehavioral development.
It is hypothesized that delayed iron will result in better neurobehavioral outcomes (as assessed by standardized cognitive and behavioral tests) due to better iron absorption and utilization.
Anticipated Impact: Untreated iron deficiency may protect a child from malaria and other infections, but the consequent potentially permanent damage to the developing brain is an unacceptable alternative. Establishment of methods to effectively ensure brain iron health while protecting the child from infection will promote attainment of full cognitive and behavioral development for tens of millions of children worldwide suffering from malaria and iron deficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Iron | Experimental | Dietary Supplement: Early IronChildren in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. |
| Delayed Iron | Experimental | Dietary Supplement: Delayed IronChildren in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months. |
| Community Control Children | No intervention | –Healthy, non-anemic community children will be enrolled from the same households and villages as the children with malaria. They will not have ZPP tested or receive iron, but they will also be under the same illness surveillance as the children with malaria. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Hemoglobin 7.0 - 9.9 g/dL
- ZPP > = 80 µmol/mol heme
- P. falciparum positive by Giemsa smear or RDT positive
- Temperature ≥ 37.5C or history of fever in past 24 hours
- Same neighborhood, extended household or nearby neighborhood of a child with malaria
Key exclusion criteria (13 listed)
- Any WHO criterion for severe malaria, including severe anemia, prostration, cerebral malaria, repeated seizures or symptoms like persistent vomiting, high temperature (>39.5°C), or tea-colored urine
- Severe malnutrition, as evidenced by severe wasting or bilateral pitting edema
- Known sickle cell disease
- Acute hemorrhage
- Known cancer or leukemia
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 |
|---|---|---|
| Early Ironiron syrup for the first three months (84 days) and placebo syrup for the fourth month | Dietary supplement | Early Iron |
| Delayed Ironplacebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months | Dietary supplement | Delayed Iron |
Primary outcome
Prevalence of iron deficiency
Time frame: 6-months
Number of participants who are iron deficient (defined as a zinc protoporphyrin (ZPP) concentration greater than or equal to 80 umol/mol heme) at 6-months follow-up in the early iron vs. delayed iron treatment groups
All-cause incidence of infectious illness
Time frame: 6-months
Number of participants who report an infection and total number of infections reported to a study medical officer in the early iron vs. delayed iron treatment groups. This includes all infectious illness including clinical malaria episodes.
Effect on neurobehavioral development: BRS
Time frame: 12-months
Behavior Rating Scales (BRS) scores at 12 months follow up in the early iron vs. delayed iron treatment groups. BRS assesses socioemotional behavior. Scores range from 1-5. Higher raw scores for Fearful/Wary Affect, Negative Affect, and Hyperactivity/Over-activity indicate less optimal behavior, as do lower raw scores for Positive Affect, Adaptation to Change, Exploration and Activity Level.
Effect on neurobehavioral development: MSEL
Time frame: 12-months
Mullen Scales of Early Learning (MSEL) scores at 12 months follow up in the early iron vs. delayed iron treatment groups.The MSEL assesses motor, visual, and language ability and is used to measure cognitive ability. Scores from fine motor, visual reception, receptive language, and expressive language scales are summed to give the early learning composite score, a measure of overall cognitive ability. Each sub-scale is standardized to calculate a standard score, percentile, and age-equivalent score. Composite scores range from 0 to 100 with 100 indicating greater cognitive ability.
10 secondary outcomes
ZPP
Time frame: 12-months
Iron status: Hemoglobin
Time frame: 6- and 12-months
Iron status: ferritin
Time frame: 6- and 12-months
Iron status: soluble transferrin receptor (sTFR)
Time frame: 6- and 12-months
Iron status: hepcidin
Time frame: 6- and 12-months
Iron status: C-reactive Protein (CRP)
Time frame: 6- and 12-months
All-cause infectious episodes
Time frame: 12-months
Proteobacteria
Time frame: Baseline, 6-months, 12-months
Child Behavior Checklist (CBCL)
Time frame: 12-months
Behaviors Related to Executive Function (BRIEF)
Time frame: 12-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 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Iron and Delayed Iron in people with Iron Deficiency Anemia and Iron-deficiency, 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 7 inclusion and 13 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 15 Jul 2025. 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. 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?
Prevalence of iron deficiency (time frame: 6-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.