University of Minnesota
Minneapolis, Minnesota, 555455, United States
Location status: Recruiting
NCT Number: NCT06527391
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.
Interested in participating?
Request Info5 month–7 month
All sexes
Interventional
Phase 2 / Phase 3
Minneapolis, Minnesota, 555455, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily supplementation for 9 months with 200 mg choline bitartrate
Daily supplementation for 9 months with identical placebo
Time frame: 9 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.
Time frame: 9 months (1 month = 28 days) after enrollment
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06042699
Adolescent Idiopathic Scoliosis, Anemia
New York, United States
View Trial DetailsNCT07577817
Anemia, Chronic Disease
Melbourne, Victoria, Australia
View Trial DetailsNCT07563582
Anemia, Celiac Disease in Children
Genova, Italy
View Trial DetailsNCT06968936
Anemia, Cardiac Surgery
Hangzhou, Zhejiang, China
View Trial Details