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Vitamin
Folic Acid Supplement [Phase 1] for Sickle Cell Anemia
N/A
Waitlist Available
Led By Crystal Karakochuk, PhD, RD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
Study Summary
This trial will test if too much folic acid is harmful to children with sickle cell disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Red Blood Cell Folate Concentration
Secondary outcome measures
Acute Pain Crises
Megaloblastic anemia
Plasma Unmetabolized Folic Acid Concentration
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Placebo [Phase 1]Experimental Treatment2 Interventions
Phase 1: Placebo for 12 weeks; Phase 2: Wash-out period (no supplement or placebo) for 12 weeks; Phase 3: Folic acid supplement (1 mg per day) for 12 weeks
Group II: Folic Acid Supplement [Phase 1]Experimental Treatment2 Interventions
Phase 1: Folic acid supplement (1 mg per day) for 12 weeks; Phase 2: Wash-out period (no supplement or placebo) for 12 weeks; Phase 3: Placebo for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic Acid Supplement
2020
N/A
~40
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,985 Total Patients Enrolled
Crystal Karakochuk, PhD, RDPrincipal InvestigatorUniversity of British Columbia
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