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NCT Number: NCT06527391

Choline and Iron Deficiency

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.

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Key information

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Minnesota

Minneapolis, Minnesota, 555455, United States

Location status: Recruiting

Location contact

Sarah Cusick

CONTACT

[email protected]

612-723-1694

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

choline bitartrate

Drug

Daily supplementation for 9 months with 200 mg choline bitartrate

Placebo drug

Other

Daily supplementation for 9 months with identical placebo

Primary outcomes

  1. Elicited Imitation score

    Time frame: 9 months (1 month = 28 days) after enrollment

    Elicited Imitation outcomes (number of items correctly recalled and number of steps recalled in the correct order for both immediate and delayed recall) at age 15 months, i.e., after nine months of daily supplementation with choline or placebo.

  2. 1) Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).

    Time frame: 9 months (1 month = 28 days) after enrollment

    • Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Cusick

CONTACT

[email protected]

612-723-1694

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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