Folic Acid for Anemia of Prematurity
(FASCINATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether extra folic acid for extremely preterm infants improves hemoglobin levels and reduces the need for blood transfusions. Folic acid is crucial for growth and DNA production, but premature babies often lack sufficient amounts from their diet. The research tests two groups: one receives additional folic acid, and the other does not. Babies born before 29 weeks, who are at least 14 days old, and consuming a minimum set amount of food, may qualify for this study. As an unphased study, this trial provides a unique opportunity to contribute to important research that could enhance care for preterm infants.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that folic acid supplementation is likely to be safe for extremely preterm infants?
Research has shown that folic acid is generally safe for use. The FDA has approved it to treat certain types of anemia caused by folic acid deficiency, indicating it is usually well-tolerated. Premature babies often need extra folic acid because breast milk might not provide enough. Studies indicate that folic acid can help increase hemoglobin levels, which is important for preventing anemia.
In past studies, babies who received folic acid and vitamin B-12 had higher hemoglobin levels, suggesting folic acid's effectiveness in managing anemia. Although specific information on side effects in premature babies is limited, folic acid is generally considered safe and important for their growth and development.12345Why are researchers excited about this trial?
Unlike the standard treatments for anemia of prematurity, which often involve blood transfusions or erythropoiesis-stimulating agents, folic acid offers a different approach. Researchers are excited about folic acid because it is a simple, oral supplement that may support red blood cell production naturally without the need for more invasive procedures. This treatment stands out because it uses folic acid, an essential B-vitamin, to potentially enhance the body's own ability to produce healthy blood cells, offering a potentially safer and more accessible option for managing anemia in premature infants.
What evidence suggests that folic acid might be an effective treatment for anemia of prematurity?
Research suggests that folic acid might help reduce anemia in premature babies. In this trial, the experimental group will receive oral folic acid supplementation, while the control group will not receive additional folic acid. These babies often lack sufficient folic acid because breast milk doesn't provide the recommended amount for them. Although limited data directly links folic acid to improvements in anemia in these infants, it is known to be important for growth and DNA synthesis. Folic acid has also reduced anemia when taken with iron during pregnancy. However, more evidence is needed to confirm its effectiveness in preventing anemia in premature babies.13678
Who Is on the Research Team?
Belal M Alshaikh, MD
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for extremely preterm infants who are at risk of developing anemia, a condition where there's not enough healthy red blood cells. The study aims to include those who might benefit from extra folic acid, which is crucial for growth and DNA synthesis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral folic acid 50 mcg daily starting at 14 days of age
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Folic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor