300 Participants Needed

Choline for Iron Deficiency

SC
Overseen BySarah Cusick
Age: < 18
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of Minnesota
Must be taking: Iron supplements
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding choline to iron therapy can enhance brain development in infants with iron deficiency anemia. Researchers believe that choline, a nutrient, may improve memory and recognition skills when combined with iron. The study will compare infants receiving iron plus choline to those receiving iron plus a placebo. Infants around 6 months old, diagnosed with iron deficiency anemia and without conditions like severe malnutrition or developmental disorders, may be eligible. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of infants, providing an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that taking choline positively affects brain development, especially when iron levels are low. Although choline has not been specifically tested in children with iron deficiency anemia, research on other groups and animals suggests it helps improve brain function. So far, these studies have not reported any major safety concerns, indicating that choline is generally safe. As this trial is in the later stages, existing safety data supports its use, but more specific information will be collected during the trial.12345

Why are researchers excited about this study treatment for iron deficiency?

Choline is unique because it offers a new approach to treating iron deficiency by potentially enhancing the body's ability to absorb and utilize iron more efficiently. Unlike traditional treatments such as iron supplements or dietary changes, which primarily focus on increasing iron intake, choline targets the underlying metabolic processes that can improve iron absorption. Researchers are excited about choline because it may provide a more effective and faster way to combat iron deficiency without the common side effects associated with high-dose iron supplements. This could be a game-changer for individuals who struggle with existing iron treatments.

What evidence suggests that choline might be an effective treatment for iron deficiency anemia?

Research shows that choline supplements may reduce the negative effects of early-life iron deficiency on brain development. Studies have found that choline can improve memory and behavior, particularly in conditions like fetal alcohol syndrome and Down syndrome. In animal studies, choline lessened the impact of iron deficiency on the brain. This trial will test choline in children with iron deficiency anemia to determine if it can improve brain function when combined with iron therapy. Although choline has not been specifically tested in children with this condition before, current evidence supports its potential benefits for brain development.12678

Who Is on the Research Team?

SC

Sarah Cusick

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for 6-month-old infants diagnosed with iron deficiency anemia. They must have specific blood test results indicating anemia, a normal body temperature, and be malaria-negative. Their mothers should not have HIV. Infants outside the age range or with other health conditions are excluded.

Inclusion Criteria

I am about 6 months old.
My hemoglobin level is below 11.0 g/dL.
My zinc protoporphyrin levels are 80 or higher.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily choline or placebo supplements along with iron for nine months

9 months

Follow-up

Participants are monitored for neurobehavioral outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Choline
Trial Overview The study tests if adding choline to standard iron treatments improves memory in infants with iron deficiency anemia. It's a randomized trial where half of the 300 participants get choline plus iron, and the other half receive a placebo plus iron for nine months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: study groupExperimental Treatment1 Intervention
Group II: control groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Prenatal Choline Supplementation Diminishes Early-Life ...Choline supplementation reduced the effects of iron deficiency, including those on gene networks associated with autism and schizophrenia. Conclusions: Fetal- ...
Study Details | NCT06527391 | Choline and Iron DeficiencyCholine has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development ...
Choline Supplementation Partially Restores Dendrite ...Early life choline supplementation also improves neurobehavioral outcomes in animal models of Down and fetal alcohol syndromes and early life iron deficiency ...
Identification of Genes Responding to Iron or Choline ...Compared with iron therapy alone, prenatal choline treatment of ID resulted in fewer residual ID effects, where notable remaining effects were ...
Early-Life Iron Deficiency Anemia Programs the ...Thus, choline supplementation may be an effective treatment for developmental ID amenia by targeting the epigenetic mechanisms underlying the long-term ...
Prenatal Choline Supplementation Ameliorates the Long ...The present study demonstrates that fetal-neonatal iron deficiency results in reduced SA and impaired recognition memory in adulthood. We used the NOR task ...
Choline and Iron Deficiency - ClinicalTrials.VeevaBACKGROUND: Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron ...
Prenatal Iron Deficiency and Choline Supplementation ...Early-life iron deficiency (ID) causes long-term neurocognitive impairments and gene dysregulation that can be partially mitigated by prenatal choline ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity