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.
Choline and Iron Deficiency
At a glance
Conditions
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.
Study leadership
- Sarah Cusick · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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).