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New treatment option for Pediatric Iron Deficiency
Official title Choline and Iron Deficiency
ClinicalTrials.gov ID: NCT06527391
What this study is testing
What is choline bitartrate?
choline bitartrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for pediatric iron deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 7
You may be able to join if
- Age 6 months +/- 28 days
- Hb \< 11.0 g/dL
- ZPP \> = 80
- T\<37.5°C
- Malaria-negative based on Rapid Diagnostic Test (RDT)
You likely can't join if
- Developmental disorder
- Severe malnutrition (severe wasting or bipedal edema)
- Known sickle cell disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
- Birthweight \< 2000 g
See the full eligibility criteria
- Age 6 months +/- 28 days
- Hb \< 11.0 g/dL
- ZPP \> = 80
- T\<37.5°C
- Malaria-negative based on Rapid Diagnostic Test (RDT)
- Mother is HIV-negative.
- Developmental disorder
- Severe malnutrition (severe wasting or bipedal edema)
- Known sickle cell disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
- Birthweight \< 2000 g
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 months to 7 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.