Recruiting
Phase 2
Phase 3

Iron with Choline

Sponsor:

University of Minnesota

Code:

NCT06527391

Conditions

Pediatric Iron Deficiency

Anemia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

choline bitartrate

placebo drug

Study Details

Brief 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.

Conditions

Pediatric Iron Deficiency

Anemia

Study ID

NCT06527391

Start date

Aug 11, 2025

Status verified date

Aug, 2026

Completion date

Sep 21, 2027

Anticipated

Primary completion date

Sep 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: study group

participants assigned to receive study drug

placebo comparator: control group

participants assigned to receive placebo drug

Interventions

choline bitartrate

Daily supplementation for 9 months with 200 mg choline bitartrate

placebo drug

Daily supplementation for 9 months with identical placebo

Primary outcome measure

  • Elicited Imitation score [ Time Frame: 9 months (1 month = 28 days) after enrollment ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 555455

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • iron deficiency
  • choline
  • anemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-05.