Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527391
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Choline and Iron Deficiency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency the SupCHO Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None