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NCT06527391 · ClinicalTrials.gov registry record · Phase 2
Choline and Iron Deficiency
A Phase 2 study of Anemia and Pediatric Iron Deficiency, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT06527391 is a Phase 2 study of Anemia and Pediatric Iron Deficiency that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 300 participants, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06527391, a Phase 2 study of Anemia and Pediatric Iron Deficiency, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG choline bitartrate
- OTHER placebo drug
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2027-09-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06527391
The ClinicalTrials.gov registry entry for NCT06527391 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (29% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which choline bitartrate is the first listed.
NCT06527391 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06527391 about?
NCT06527391 is a clinical study titled "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 ag...
What is the current status of trial NCT06527391?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-08-11. Estimated completion is 2027-09-21.
What conditions does trial NCT06527391 study?
This clinical trial studies the following conditions: Anemia, Pediatric Iron Deficiency.
What interventions are being tested in trial NCT06527391?
The interventions under investigation include: choline bitartrate (DRUG), placebo drug (OTHER).
Who is sponsoring clinical trial NCT06527391?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06527391 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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