Folic Acid for Anemia of Prematurity

(FASCINATE Trial)

Overseen By Belal Alshaikh, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Congenital anomalies, Pulmonary hemorrhage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20-22 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants. Despite the adoption of folic acid supplementation, evidence supporting its effectiveness in preventing AOP remains scarce. Recommendations for folic acid intake exceed what's naturally found in breast milk, particularly for extremely low birthweight infants. Practices regarding folic acid supplementation vary widely, prompting the need for research. The FACINATE trial aims to determine if additional folic acid supplementation improves hemoglobin levels and reduces late blood transfusions in extremely preterm infants, a question not addressed in current literature.

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.

What data supports the effectiveness of the drug folic acid for anemia of prematurity?

Research indicates that folic acid can help address folate deficiency in preterm infants, which is common and can be diagnosed by changes in blood cells. Supplementing with folic acid has been shown to improve blood health in these infants, suggesting it may be beneficial for managing anemia of prematurity. ^{1 2 3 4 5}

Is folic acid safe for human use?

Folic acid is generally considered safe for human use, with extensive research supporting its safety, especially in preventing birth defects. However, there are concerns about high intake potentially promoting cancer in some people, so it's important to monitor intake levels. ^{6 7 8 9 10}

How does the drug folic acid differ from other treatments for anemia of prematurity?

Folic acid is unique in treating anemia of prematurity because it specifically addresses folate deficiency, which is common in preterm infants. Unlike other treatments, folic acid can be administered orally or via injection and helps replenish tissue folate stores, which is crucial for optimal blood cell production in these infants. ^{2 3 11 12 13}

Research Team

Belal M Alshaikh, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

My baby is at least 14 days old.

My baby was born before 29 weeks and is admitted to Foothill Medical Centre.

On minimum enteral feeding of 100 mL/kg/day

Exclusion Criteria

Infants with major congenital or chromosomal anomalies

My infant has had lung or stomach bleeding within the first 14 days of life.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral folic acid 50 mcg daily starting at 14 days of age

20-22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Folic Acid

Trial Overview The FACINATE trial tests if giving additional folic acid to these infants can improve their hemoglobin levels (which carry oxygen in the blood) and reduce the need for late-stage blood transfusions.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Oral folic acid 50 mcg daily starts at 14 days of age

Group II: Control Active Control 1 Intervention

No additional folic acid supplementation

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A rational approach to red blood cell transfusion in the neonatal ICU. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Diagnosis and management of folate deficiency in low birthweight infants. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Red cell folate and plasma homocysteine in preterm infants. [2013]

4. Spain pubmed.ncbi.nlm.nih.gov

[Prophylaxis of anemia of prematurity with erythropoietin. Case control study]. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a combined therapy of erythropoietin, iron, folate, and vitamin B12 on the transfusion requirements of extremely low birth weight infants. [2013]

6. Poland pubmed.ncbi.nlm.nih.gov

[Folic acid: new indications for an old well-known drug]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Will mandatory folic acid fortification prevent or promote cancer? [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Folic acid food fortification-its history, effect, concerns, and future directions. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Folic acid for the prevention of congenital anomalies. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of folic acid. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Plasma and red cell folate values and folate requirements in formula-fed premature infants. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Folic acid supplementation in low birth weight infants. [2013]

13. Venezuela pubmed.ncbi.nlm.nih.gov

Prematurity and maternal folate deficiency: anemia during pregnancy study group results in Valencia, Venezuela. [2016]