Status:
COMPLETED
Folic Acid Supplementation in Children With Sickle Cell Disease
Lead Sponsor:
University of British Columbia
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
2-19 years
Phase:
NA
Brief Summary
Folic acid supplementation (1mg/d) is the standard recommendation for Canadian children with Sickle cell disease (SCD), even though it can provide up to six times the recommended intake amount for hea...
Detailed Description
Blood samples will be collected at baseline and 12-wk of each treatment period (weeks 12, 24, and 36). Serum and RBC concentrations of total folate, different folate forms and clinical outcomes will ...
Eligibility Criteria
Inclusion
- Individuals with SCD aged 2-19 y attending British Columbia Children's Hospital
- Individuals having received routine daily supplementation of folic acid for the prior 12-weeks
Exclusion
- Individuals receiving a blood transfusion in the prior 12-weeks
- Individuals allergic to any components of the supplement (cellulose, methylcellulose, magnesium stearate, and/or titanium dioxide)
- Individuals presenting with megaloblastic anemia in the prior 12-weeks
- Individuals with pulmonary, renal and/or cardiac complications (severe or recurrent acute chest syndrome)
- Individuals routinely taking medications known to interfere with B vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, primidone, triamterene, barbiturates)
- Individuals who are currently pregnant, planning to become pregnant in the next 9-months, or currently breastfeeding
- Individuals who have participated in a clinical research trial in the previous 30 days
- Individuals who have donated blood in the previous 30 days
- Individuals with unstable medical conditions or unstable laboratory results.
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04011345
Start Date
November 23 2020
End Date
October 31 2022
Last Update
August 24 2023
Active Locations (1)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1