Choline and Iron Deficiency

Last updated: August 26, 2025
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

2/3

Condition

Anemia

Treatment

placebo drug

choline bitartrate

Clinical Study ID

NCT06527391
33410
  • Ages 5-7
  • All Genders

Study Summary

BACKGROUND:

Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.

GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.

HYPOTHESIS:

Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.

METHODS:

This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.

RESULTS: Pending

IMPACT:

If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 6 months +/- 28 days

  • Hb < 11.0 g/dL

  • ZPP > = 80

  • T<37.5°C

  • Malaria-negative based on Rapid Diagnostic Test (RDT)

  • Mother is HIV-negative.

Exclusion

Exclusion Criteria:

  • Developmental disorder

  • Severe malnutrition (severe wasting or bipedal edema)

  • Known sickle cell disease

  • Neurologic disorder, brain injury, or other condition affecting brain development

  • Not currently breastfeeding

  • Birthweight < 2000 g

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: placebo drug
Phase: 2/3
Study Start date:
August 11, 2025
Estimated Completion Date:
September 21, 2027

Connect with a study center

  • University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 555455
    United States

    Active - Recruiting

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