A Phase 2/3 interventional study of choline bitartrate and placebo drug in Pediatric Iron Deficiency and Anemia, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 5 Months to 7 Months. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Minnesota · Phase 2/3, Interventional, and Prevention
Among 464 studies in Anemia with a site in United States — 38 open to participants now, 59 under way, 19 of them phase 3. Anemia · United States.
Among the 464 studies in Anemia with a site in United States, this one is the 83rd largest by planned enrollment of the 395 interventional ones that give a count, is one of 10 that started in 2025, is one of 8 in phase 2/3, reaches primary completion later than 30 of the 57 other live ones, and was the 441st registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 300 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →38 of the 464 studies in Anemia with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 5 Months to 7 Months · all sexes · no healthy volunteers.
The full table on the hub →464 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 71 · Phase 2 136 · Phase 3 122 · Phase 4 34
First in 1992; this study’s year is marked. 10 started in 2025.
Median enrollment 72 across the 395 interventional studies, 116 across the 50 observational. Of the 366 that completed or were terminated, 196 (54%) have results posted.
231 of 464 have an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 4 studies filed under Anemia — fewer than ten, so there is no comparison to draw.
10 of the studies in Anemia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06527391Phase 3University of MinnesotaCholine and Iron Deficiency | 2027-09-21 |
| NCT04747613Phase 3Novartis PharmaceuticalsLong-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2027-10-18 |
| NCT06106269Mayo ClinicOutcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids | 2026-12 |
| NCT05340465University of WashingtonDarbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants | 2027-01-30 |
| NCT06788691Weill Medical College of Cornell UniversityLuspatercept for Clonal Cytopenias of Uncertain Significance | 2027-02 |
Among the 464 studies in Anemia with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants assigned to receive study drug
Drug: choline bitartrate
participants assigned to receive placebo drug
Other: placebo drug
Daily supplementation for 9 months with 200 mg choline bitartrate
Daily supplementation for 9 months with identical placebo
Elicited Imitation score
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.
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).
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
Started Aug 2025 (actual). Primary completion is estimated for Sep 2027, 25 months after the start.
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Studies of the drug tested here: Choline