Choline and Iron Deficiency Study for Infants

This study is looking at whether a nutrient called choline bitartrate can help with brain development in infants who have iron deficiency and anemia. Iron deficiency can affect how a child's brain develops, and current treatments don't always fully fix the problem. Researchers want to see if choline bitartrate, given daily for 9 months, can help. You might be able to join if your baby is between 5 and 7 months old, has low hemoglobin (a protein in red blood cells that carries oxygen), and meets other health requirements like being malaria-negative. The study will measure your child's learning and attention skills after 9 months to see if the choline bitartrate made a difference. This study plans to enroll 300 participants.

Study design
This is an interventional study where participants will receive either choline bitartrate or a placebo daily for 9 months.
What's involved
Participants will receive daily supplementation for 9 months. Learning and attention skills will be measured at 9 months after enrollment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 months after enrollment, which is when the primary endpoints are measured.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06527391

Choline and Iron Deficiency

Recruiting
PHASE2Ages 5–7InterventionalPrevention
University of Minnesota
~300 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:choline bitartrateplacebo drug

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Elicited Imitation score
Measured over 9 months (1 month = 28 days) after enrollment
+1 more outcome measured
Pediatric Iron Deficiency
Anemia

NCT06527391

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Sarah Cusick · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

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

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
  • Elicited Imitation score9 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.

  • 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).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).